biomaterial collection

---

BIOMATERIAL COLLECTION

www.implantdirect.com | 888.649.6425

INDEX

GRAFTING Xenograft Allograft

Synthetic

PAGE Bone Grafting Bone Grafting Bone Grafting Bone Grafting Soft Tissue Grafting Bone Grafting

DirectOss™ DirectGen™ DirectGen™ Putty DirectGen™ FLEX DirectGen™ DERM BioResorb® Macro Pore

1 2-3 4 5 6 7

MEMBRANES Resorbable

Non-Resorbable

Kontour™ Adapt Kontour™ Sustain CytoPlast® RTM CytoPlast® TI250, TXT & GBR

8 9 10 11

BIO-XC™ Plug BIO-XC™ Foam BIO-XC™ Tape

12

Vilet™ CytoPlast®

13 14

WOUND DRESSINGS Resorbable

Xenograft

SUTURES Resorbable Non-Resorbable

Availability Not all products listed in this catalog are available in all countries. Please contact Implant Direct or your local dealer for more information on product availability.

DirectOss™

BONE GRAFTING - XENOGRAFT

DirectOss allows you slow resorbing support for integrative new bone growth enabling you to treat bony defects with confidence. This natural hydroxyapatite extracted from bovine cancellous bone boasts greater inner surface area than comparable materials on the market – giving it more space for osteoblast adhesion as well as high hydrophilicity for rapid vascularization. ANORGANIC CANCELLOUS GRANULES • 100% natural hydroxyapatite extracted from bovine cancellous bone • Derived from BSE-free herds in Australia • Mimics human bone both structurally and chemically • Sintered at a low temperature to reduce crystallinity content • Supports new bone in-growth throughout each granule due to its interconnected macro, meso and micro pore structure • Packaged in both vials and syringes for easy delivery • Gamma irradiated to SAL 10-6 for sterility COMMON APPLICATIONS Socket preservation Maxillary sinus floor elevation Alveolar ridge augmentation Periodontal regeneration Defects associated with implants

DirectOss has up to 55% greater inner surface to support new bone in-growth

Inner Surface Area (m2/g)

100 80

Granule Size

Weight

Packaging

Reference #

0.25-1.0mm 0.25-1.0mm 0.25-1.0mm 0.25-1.0mm

0.25g 0.50g 1.0g 2.0g

Vial Vial Vial Vial

DXCA251025 DXCA251005 DXCA251010 DXCA251020

0.25-1.0mm 0.25-1.0mm 0.25-1.0mm

0.25cc (≈0.125g) 0.5cc (≈0.25g) 1.0cc (≈0.5g)

Syringe Syringe Syringe

DXCA251025S DXCA251005S DXCA251010S

1.0-2.0mm 1.0-2.0mm

0.50g 2.0g

Vial Vial

DXCA102005 DXCA102020

88.2 79.7

60

57.0 40 20 0 DirectOss™ Bio-Oss™

NuOss™

Ref. NuOss, a Bone Grafting Material for Oral Surgery: A Comparative Study with BioOss by Collagen Matrix Inc. Ref. Biomaterials 2001; 22:1005-1012

1

DirectGen™

BONE GRAFTING-ALLOGRAFT

DirectGen™ Allograft is a natural, safe and easy to use grafting material. This product comes in a variety of donated tissue types (cortical, cancellous or cortical-cancellous blend) and is suited for a wide range of clinical needs. DirectGen has been processed utilizing a proprietary process. This process allows for microbial inactivation while minimally manipulating the tissue. This process meets or exceeds requirements set forth by the FDA and American Association of Tissue Banks (AATB) and in addition, there have been no confirmed cases of disease transmission from allografts in its extensive history.

Cancellous Particulate DirectGen Mineralized cancellous particulate has the interconnecting porosity associated with trabecular bone structure. This allows for increased capillary action of the blood which in turn promotes rapid formation of osteoblasts for new bone growth. • Has increased porosity and surface area which promotes revascularization and supports in-growth of new bone

Cortical Particulate DirectGen Mineralized cortical particulate offers the structural strength and integrity associated with cortical bone. This results in a slower resorbing graft material that is ideal for space maintenance in grafting procedures. • Provides longer lasting scaffold for new bone ingrowth

Cortical-Cancellous Blend DirectGen Mineralized Blend is a 50:50 mixture of cortical and cancellous particulate. This pre-mixed, easy to use product is intended to provide the clinician with the features and benefits of both tissue types. • Simplifies procedure by eliminating need to mix tissues chairside • Single donor per vial

Demineralized Cortical Particulate DirectGen Demineralized particulate has been processed to expose the bone morphogenic proteins within the bone matrix. This results in a graft material that has the potential to induce cell differentiation and new bone formation. • Each lot is tested via BMP-2 assay POST sterilization

DirectGen Mineralized/Demineralized Cortical Combo DirectGen Mineralized/Demineralized Cortical Combo is a 50:50 combination of mineralized cortical tissue and demineralized cortical tissue. This pre-mixed combination results in a material with osteoconductive properties as well as osteoinductive potential. • Saves time and effort by eliminating need to mix tissues chairside • Mineralized content ideal for space maintenance while demineralized content provides osteoinductive potential

2

www.implantdirect.com

DirectGen Packaging

Allograft: DirectGen Mineralized Cortical (250-1000μm) - 0.5cc

DCOR251005

(250-1000μm) - 1.0cc

DCOR251010

(250-1000μm) - 2.0cc

DCOR251020

(1000-2000μm) - 0.5cc

DCOR102005

(1000-2000μm) - 1.0cc

DCOR102010

(1000-2000μm) - 2.0cc

DCOR102020

Allograft: DirectGen Mineralized Cancellous

Item#

(250-1000μm) - 0.5cc

DCAN251005

(250-1000μm) - 1.0cc

DCAN251010

(250-1000μm) - 2.0cc

DCAN251020

(1000-2000μm) - 0.5cc

DCAN102005

(1000-2000μm) - 1.0cc

DCAN102010

(1000-2000μm) - 2.0cc

DCAN102020

Allograft: DirectGen Mineralized Cortical/Cancellous blend

Item#

(250-1000μm) - 0.5cc

DBLN251005

(250-1000μm) - 1.0cc

DBLN251010

(250-1000μm) - 2.0cc

DBLN251020

Allograft: DirectGen Demineralized Cortical (125-850μm) - 0.5cc (125-850μm) - 1.0cc (125-850μm) - 2.0cc

Allograft: DirectGen Mineralized/ Demineralized Cortical Combo

www.implantdirect.com

Item#

Item# DDCOR128505 DDC0R128510 DDCOR128520

Item#

(125-1000μm) - 0.5cc

DCMB121005

(125-1000μm) - 1.0cc

DCMB121010

(125-1000μm) - 2.0cc

DCMB121020

3

DirectGen™ PUTTY BONE GRAFTING - PUTTY

Innovation often follows the straightest path. In bone grafting, attention to basic fundamentals has always been the key to the best and most predictable clinical outcomes. Historically, bone itself is the best substrate for new bone formation. This is the philosophy behind DirectGen Putty, which is simply comprised of human bone and buffered water.

DEMINERALIZED PUTTY • Made from 100% human bone – nothing added that may get in the way of bone healing • Osteoconductive – DBM provides an ideal scaffold that directs and supports bone formation • Osteoinductive – the osteoinductive potential of DBM is well established • Excellent handling characteristics – will shape and conform to fill unique bony voids, retains shape and resists wash-out, or migration, from graft site • Easy to store and use – stores at ambient room temperature, long three-year shelf life, and ready for immediate use; no prep time or reconstitution required • Sterile – gamma irradiated to SAL 10-6 • Safe – donor recovery and screening performed according to AATB and FDA guidelines • Clinically versatile – available in a flowable putty or as a flowable putty plusmineralized chips

Available in two options and a variety of sizes: DirectGen Putty

Size

DP070 DP100 DP250

0.7cc 1.0cc 2.5cc

DirectGen Putty PLUS Size DPP100 DPP250

4

1.0cc 2.5cc

www.implantdirect.com

DirectGen™ FLEX BONE GRAFTING - ALLOGRAFT

DEMINERALIZED CORTICAL ALLOGRAFT SHEET • Proprietary processing leaves cortical sheet flexible which allows it to be easily adapted to act as missing wall in 3 wall defect or as an onlay to cover a graft site • Product retains enough rigidity to allow it to be easily tucked into periosteal envelope (as compared to a membrane) and maintains its position during flap closure and suturing • Rehydrates in minutes and can be easily shaped with scissors or scalpel. Can be tacked or sutured • Provides 3 dimensional osteoconductive scaffold that promotes revascularization and in-growth of new bone • Demineralization process exposes BMP-2 content native in the tissue. Each LOT is assayed and tested for its osteoinductive potential post sterilization

COMMON APPLICATIONS Repair of 3 wall defects Repair of access windows Ridge Augmentations

DirectGen FLEX inserted subperiostelly to act as temporary wall

10mm x 10mm

10mm x 17mm

15mm x 15mm

DFLX1010 (1/box)

DFLX1017 (1/box)

DFLX1515 (1/box)

www.implantdirect.com

5

DirectGen™ DERM SOFT TISSUE GRAFTING - ALLOGRAFT

DECELLURIZED DERMAL ALLOGRAFT TISSUE • Biocompatible • Retains collagen and elastin and has elasticity of the native dermis • Processing preserves biologic properties that promote revascularization and repair of damaged tissues • Eliminates morbidity and pain associated with a donor site • Allows multiple sites to be treated in same surgery • Proprietary processing allows either side to be placed against defect. No special orientation required • Rehydrates in minutes and is easily trimmed with scalpel or scissors • Retains enough firmness when hydrated to facilitate easy placement in graft site (especially when used for tunnel technique)

Available in multiple thickness and size options: Thin (0.5-1.0mm) DD101005 DD102005 DD104005 DD204005

Thick (1.0-1.5mm) DD101010 DD102010 DD104010 DD204010

Pre-op

6

DirectGen DERM trimmed for site

Insertion of DirectGen DERM

Site sutured

Size 10x10mm 10x20mm 10x40mm 20x40mm

Size 10x10mm 10x20mm 10x40mm 20x40mm

4 week post-op Case courtesy of Avi Schetritt, DMD

www.implantdirect.com

βioResorb® Macro Pore BONE GRAFTING-SYNTHETIC

β-TRICALCIUM PHOSPHATE BONE REGENERATION MATERIAL WITH ADVANCED POROSITY βioResorb® Macro Pore is an osteoconductive, pure-phase β-Tricalcium phosphate bone grafting material developed via a patented process that creates a porous structure most similar to human bone. The interconnecting micro & macro porous structure gives the advantage of allowing vascularization and cell transport into and throughout the particle, leading to new bone deposits within the particles themselves. βioResorb Macro Pore is made from 99% pure-phase Beta Tri-Calcium Phosphate (β-TCP). Each batch of product is tested via X-ray diffraction to ensure its purity. In addition, the calcium/phosphor atom ratio in βioResorb is 1.5 (very similar to the mineral phase of human bone which is 1.6).

Histology at 7 months – improved bone regeneration with a high activity of osteoblasts, homogenous cortical Odontogenic keratocyst

structures and no signs of inflammation.

6 months after cyst removal and placement of βioResorb® Macro Pore. Complete restitution of bone structure.

βioResborb Macro Pore Single pack (1 vial/1 box) 200-500μm

Item#



0.5ml

19002105

500-1000μm

0.5ml

19005105





1.0ml

19005110





2.0ml

19005120

1.0ml

19014110

1400-3200μm

βioResborb Macro Pore 5- pack (5 vials/1 box) 200-500μm

Item#



0.5ml

19002505

500-1000μm

0.5ml

19005505





1.0ml

19005510





2.0ml

19005520

www.implantdirect.com

7

MEMBRANES

Kontour™ Adapt RESORBABLE MEMBRANE

TYPE I PORCINE PERITONEUM COLLAGEN RESORBABLE MEMBRANE • Resorbable; new host collagen is regenerated as membrane resorbs • Easy to use; not side specific and easily conforms to defects and contours • Can be used dry or hydrated. Membrane does not stick to instruments or gloves when hydrated and can be easily repositioned once placed • Membrane’s proprietary process assures the membranes are highly biocompatible resulting in minimal inflammation and foreign body response • Membrane has excellent strength to support tacking or suturing • Initial slower rate of resorption protects wound during early critical period of healing • Protects wound from undesired in­growth of soft tissue • Provides effective barrier functionality for up to 12­-16 weeks

COMMON APPLICATIONS Periodontal defects

Reference#

Description

KRMA1520 KRMA2030 KRMA3040

15x20mm membrane (1/box) 20x30mm membrane (1/box) 30x40mm membrane (1/box)

Sinus lift osteotomies Repair of access windows Soft tissue augmentation Periapical lesions

SEM micrograph of the Kontour Adapt (side A) at 50x magnification

www.implantdirect.com

SEM micrograph of the Kontour Adapt (side B) at 50x magnification

SEM micrograph of the Kontour Adapt (cross-section) at 50x magnification

8

Kontour™ Sustain RESORBABLE MEMBRANE

TYPE I PORCINE COLLAGEN RESORBABLE MEMBRANE • Fully Resorbable; no second surgery required • Easy to use; either side may be placed against defect • Can be used dry or hydrated. Hydrates in minutes. Membrane does not stick to itself when hydrated allowing for easy placement and/or repositioning • Membrane retains sufficient memory when hydrated which allows it to be easily positioned under the periosteum uniformly without bunching up. This also allows the membrane to maintain its shape and position during closing, suturing and throughout its use • Membrane is also soft and conformable. This allows membrane to adapt well to most varying bone topographies • Unique fiber orientation provides membrane with high tensile strength and high suture pullout resistance • Provides effective barrier functionality for 16-24 weeks

COMMON APPLICATIONS Periodontal defects Sinus lift osteotomies Repair of access windows Soft tissue augmentation Periapical lesions 50X Magnification

9

15mm x 20mm

20mm x 30mm

30mm x 40mm

KRM1520 (1/box)

KRM2030 (1/box)

KRM3040 (1/box)

www.implantdirect.com

CytoPlast® RTM RESORBABLE MEMBRANE

TYPE I BOVINE COLLAGEN RESORBABLE TISSUE MATRIX • Resorbable; eliminates second surgery • Unique fiber orientation provides unusually high tensile strength • Safe; manufactured from highly purified Type I bovine achilles tendon • Layered construction allows cellular ingrowth of outer layer, but inner layers help prevent cellular and bacterial downgrowth • Longer predictable resorption time of 26 to 38 weeks • Guides healing of bone and surrounding tissue • High mechanical strength for membrane stabilization using either sutures or resorbable tacks • Excellent handling when wet, and either side can be placed against the defect • Optimized flexibility and rigidity for better maintenance of space

COMMON APPLICATIONS Periodontal defects Sinus lift osteotomies Repair of access windows Soft tissue augmentation Periapical lesions

This cross sectional SEM view demonstrates the multi-layer construction allowing tissue integration in outer layer while preventing direct passage of bacteria and epithelial cells.

CYTOPLAST® RTM COLLAGEN

15mm x 20mm

20mm x 30mm

30mm x 40mm

RTM1520 (2/box)

RTM2030 (2/box)

RTM3040 (2/box)

www.implantdirect.com

10

CytoPlast® TI250, TXT & GBR

NON-RESORBABLE AND NON-RESORBABLE TITANIUM REINFORCED MEMBRANES

THE ORIGINAL, PATENTED, HIGH-DENSITY PTFE MEMBRANE • Non-resorbable; won’t resorb prematurely leaving graft site exposed • Made from d-PTFE; <0.3um pore size is impervious to bacteria • Primary closure not required; less surgical time required • Soft tissue attaches but does not grow through membrane; allows for non-surgical removal • Textured surface; increases membrane stabilization • Titanium Insert (on TI250 membranes) provides membrane with shape memory and rigidity for superior space creation and maintenance while grafting

CYTOPLAST® TXT & GBR Cytoplast TXT2530

Cytoplast TXT1224

25mm x 30mm (4 membranes/box)

12mm x 24mm (10 membranes/box)

Cytoplast GBR2530

Cytoplast GBR1224

25mm x 30mm (4 membranes/box)

12mm x 24mm (10 membranes/box)

CYTOPLAST® TI250 12mm x 24mm

14mm x 24mm

Cytoplast Ti250 Anterior Narrow

Cytoplast Ti250 Anterior Single

Ti250ANL-1 (1 membrane/box) Ti250ANL-2 (2 membranes/box)

Ti250AS-1 (1 membrane/box) Ti250AS-2 (2 membranes/box)

Ideal for narrow single-tooth extraction sites, especially where one or more bony walls are missing.

Ideal size and shape for single-tooth extraction sites, especially where one or more bony walls are missing.

25mm x 30mm

20mm x 25mm

17mm x 25mm

Cytoplast Ti250 Posterior Large

Cytoplast Ti250 Posterior Singles

Cytoplast Ti250 Buccal

Ti250PL-1 (1 membrane/box) Ti250PL-2 (2 membranes/box)

Ti250PS-1 (1 membrane/box) Ti250PS-2 (2 membranes/box)

Ti250BL-1 (1 membrane/box) Ti250BL-2 (2 membranes/box)

Designed for grafting large bony defects, including ridge augmentation.

Designed for grafting posterior extraction sites and limited ridge augmentation.

Ideal for use in large buccal defects. The pilot holes create more secure membrane stabilization.

11

This SEM view shows the micro-machined textured surface, which increases the area available for cellular attachment by 250% without increasing porosity.

www.implantdirect.com

WOUND DRESSINGS

BIO-XC™

RESORBABLE WOUND DRESSINGS

Resorbable Wound Dressings are absorbent, porous, collagen matrices engineered from purified collagen derived from bovine dermis tissue.

FEATURES • Applied directly to the wound and protect the wound and delicate new tissue • Aids in wound healing • Available as a plug (BIO-XC™ Plug), foam (BIO-XC™ Foam), and tape (BIO-XC™ Tape) • Supplied sterile, non-pyrogenic and for single use only • Essentially resorbs within 30 days of placement

COMMON APPLICATIONS • Denture sores • Oral ulcers (non-infected or viral)

Reference#

Description

• Periodontal surgical wounds • Suture sites • Burns

BIO-XCT Tape BIO-XCF Foam BIO-XCP Plug

2.5cm x 7.5cm x 1mm 2.0cm x 4.0cm x 3.0mm 10mm x 20mm

(10 individual units per box) (10 individual units per box) (10 individual units per box)

• Extraction sites • Surgical wounds • Traumatic wounds

BIO-XC™ Tape

12

BIO-XC™ Foam

BIO-XC™ Plug

www.implantdirect.com

SUTURES

Vilet™

RESORBABLE SUTURES

Vilet™ is a braided coated synthetic absorbable suture made from polyglactin (PGLA) 90-10. CHARACTERISTICS • Maintain approximately 75-85% of its original strength at two weeks and 50-65% of its original strength at 3 weeks post implantation1 • Excellent knot security and tie down • Superb handling—Smooth Tissue Passage • Reliable absorption profile • Meets or exceeds the USP & EP requirements • Resorbs completely in 60-90 days Item #

Size (USP)

Length

Color

Needle Type

Needle Shape

QTY/Box

V393

3-0

18”

Violet

FS-2

3/8 Circle Reverse Cut 19mm

12

V393U

3-0

18”

Undyed

FS-2

3/8 Circle Reverse Cut 19mm

12

V392

4-0

18”

Violet

FS-2

3/8 Circle Reverse Cut 19mm

12

V392U

4-0

18”

Undyed

FS-2

3/8 Circle Reverse Cut 19mm

12

V386U

4-0

18”

Undyed

C-3

3/8 Circle Reverse Cut 13mm

12

V385U

5-0

18”

Undyed

C-3

3/8 Circle Reverse Cut 13mm

12

Needle Type

Needle Shape

QTY/Box 12

12

Vilet II Quick™ RESORBABLE SUTURES

Is a fast-absorbing synthetic absorbable suture composed of a coated polyglactin (PGA). ADDITIONAL CHARACTERISTICS • Maintain approximately 60-70% of its original strength after 1 week post implantation1 • Completely resorbs in 42 days Item #

Size (USP)

Length

Color

VGQ386

4-0

18”

Undyed

C-3

3/8 Circle Reverse Cut 13mm

VGQ392

4-0

18”

Undyed

FS-2

3/8 Circle Reverse Cut 19mm

Times are based on subcutaneous tissue implantation studies in rats.

1

13

www.implantdirect.com

CytoPlast®

NON-RESORBABLE SUTURES

BENEFITS • Non-resorbable, 100% Medical Grade d-PTFE • Monofilament construction eliminates bacterial wicking • Biologically inert & chemically non-reactive • Not subject to weakening by tissue enzymes • Excellent soft tissue response • Soft; increased patient comfort • Great handling, knot-tying & knot-holding characteristics

COMMON APPLICATIONS Bone grafting procedures Guided tissue regeneration Implant surgery Periodontal surgery Ridge augmentation Soft tissue grafts

Item #

Size (USP)

Length

Color

Needle Type

Needle Shape

QTY/Box

CS-04

2-0

18”

Undyed

FS-2

3/8 Circle Reverse Cut 19mm

12

CS-05

3-0

18”

Undyed

FS-21

3/8 Circle Reverse Cut 16.3mm

12

CS-051819

3-0

18”

Undyed

FS-2

3/8 Circle Reverse Cut 19mm

12

CS-06

4-0

18”

Undyed

FS-21

3/8 Circle Reverse Cut 16.3mm

12

4-0

18”

Undyed

P-3

3/8 Circle Reverse Cut 13mm

12

4-0

18”

Undyed

TP

1/2 Circle Taper Point 13mm

12

CS-06 PREM

CS-06 PERIO

1

www.implantdirect.com

Needle size smaller than typical FS-2 needle.

14

Simply Smarter Implantology Innovative Designs with Inclusive Packaging

Mount-Free Prosthetics & SMART PACKS

LOCATOR® Multi-Unit Internal Hex

Conical

....and more

Sales and Technical Support (USA & Canada) www.implantdirect.com | 888-649-6425

Call to find out which one best fits your practice!

Copyright © 2017 Implant Direct Sybron International. All Rights Reserved. Rev. 07 Printed in the U.S.A.

All trademarks are property of their respective companies. Pricing and product availability subject to change without notice. Not all products shown are available in all countries. Please contact Implant Direct or your local dealer for more information on product availability.