biomaterial collection

BIOMATERIAL COLLECTION
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Innovation.
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Service.
Value.
INDEX
GRAFTING
Allograft
Synthetic
PAGE
Bone Grafting
Bone Grafting
Bone Grafting
Bone Grafting
Soft Tissue Grafting
DirectGen™
DirectGen™ Putty
DirectGen™ FLEX
BioResorb® Macro Pore
DirectGen™ DERM
1-2
3
4
5
6
MEMBRANES
Resorbable
Non-Resorbable
7
8
9
Kontour™
CytoPlast® RTM
CytoPlast® TI250, TXT & GBR
SUTURES
Resorbable
Non-Resorbable
Vilet™
CytoPlast®
10
11
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.
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 as a result, 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
• Two different resorption rates for ideal space maintenance and exposure of bone morphogenic proteins earlier in the healing process
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1
NEW DirectGen Packaging
Allograft: DirectGen Mineralized Cortical
(250-1000μm) - 0.5cc
NEW DCOR251005
(250-1000μm) - 1.0cc
NEW DCOR251010
(250-1000μm) - 2.0cc
DMCO251020
(1000-2000μm) - 0.5cc
DMCO102005
(1000-2000μm) - 1.0cc
DMCO102010
(1000-2000μm) - 2.0cc
DMCO102020
Allograft: DirectGen Mineralized Cancellous
Item#
(250-1000μm) - 0.5cc
NEW DCAN251005
(250-1000μm) - 1.0cc
NEW DCAN251010
(250-1000μm) - 2.0cc
NEW DCAN251020
(1000-2000μm) - 0.5cc
DMCA102005
(1000-2000μm) - 1.0cc
DMCA102010
(1000-2000μm) - 2.0cc
NEW DCAN102020
Allograft: DirectGen Mineralized
Cortical/Cancellous blend
Item#
(250-1000μm) - 0.5cc
NEW DBLN251005
(250-1000μm) - 1.0cc
NEW DBLN251010
(250-1000μm) - 2.0cc
NEW DBLN251020
Allograft: DirectGen Demineralized Cortical
(125-710μm) - 0.5cc
(125-710μm) - 1.0cc
(125-710μm) - 2.0cc
Allograft: DirectGen Mineralized/
Demineralized Cortical Combo
2
Item#
Item#
NEW DDCOR128505
DDC0127110
NEW DDCOR128520
Item#
(125-1000μm) - 0.5cc
NEW DCMB121005
(125-1000μm) - 1.0cc
NEW DCMB121010
(125-1000μm) - 2.0cc
NEW DCMB121020
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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
Price (USD)
DirectGen Putty PLUS Size
DPP100
DPP250
1.0cc
2.5cc
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3
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
4
10mm x 10mm
10mm x 17mm
15mm x 15mm
DFLX1010
(1/box)
DFLX1017
(1/box)
DFLX1515
(1/box)
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BioResorb® 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
BioResborb Macro Pore
Single pack (1 vial/1 box)
Item#
200-500μm
0.5ml
19002105
500-1000μm
0.5ml
19005105
1.0ml
19005110
2.0ml
19005120
1000-2000μm
1400-3200μm
0.5ml
19010105
1.0ml
19010110
2.0ml
19010120
1.0ml
19014110
BioResborb Macro Pore
5- pack (5 vials/1 box)
Item#
200-500μm
0.5ml
19002505
500-1000μm
0.5ml
19005505
1.0ml
19005510
2.0ml
19005520
0.5ml
19010505
1.0ml
19010510
1000-2000μm
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restitution of bone structure.
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
Price (USD)
10x10mm
10x20mm
10x40mm
20x40mm
Size
10x10mm
10x20mm
10x40mm
20x40mm
4 week post-op
Case courtesy of Avi Schetritt, DMD
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MEMBRANES
Kontour™
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
7
15mm x 20mm
20mm x 30mm
30mm x 40mm
KRM1520
(1/box)
KRM2030
(1/box)
KRM3040
(1/box)
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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)
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8
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 nonsurgical 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) $110
Ti250ANL-2 (2 membranes/box) $200
Ti250AS-1 (1 membrane/box) $140
Ti250AS-2 (2 membranes/box) $250
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) $200
Ti250PL-2 (2 membranes/box) $365
Ti250PS-1 (1 membrane/box) $180
Ti250PS-2 (2 membranes/box) $325
Ti250BL-1 (1 membrane/box) $150
Ti250BL-2 (2 membranes/box) $270
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.
9
This SEM view shows the micro-machined
textured surface, which increases the area
available for cellular attachment by 250%
without increasing porosity.
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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 implantation.1
• 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
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 implantation.1
• Completely resorbs in 42 days
Item #
Size (USP)
Length
Color
Needle Type
Needle Shape
QTY/Box
12
12
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
Price (USD)
Times are based on subcutaneous tissue implantation studies in rats.
1
10
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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
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Needle size smaller than typical FS-2 needle.
11
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Copyright © 2015 Implant Direct Sybron International. All Rights Reserved.
*5.5-08-15-0062*
5.5K-08-15-0062 Rev.02 Printed in the U.S.A.
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.