FDA.reportPublic FDA data

NeoGen Collagen Flex

Primary DI
05060440334153
Brand
NeoGen Collagen Flex
Company
COLLAGEN MATRIX, INC.
Model
64052
Device description
Resorbable Collagen Dental Membrane 30mm x 40mm
Published
2019-06-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NPLBarrier, Animal Source, Intraoral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NPLBarrier, Animal Source, IntraoralDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060440334153PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060440334153050604403341535060440334153

GMDN Terms#

Term, Definition table
TermDefinition
Collagen dental regeneration membraneA sterile bioabsorbable material intended to be used to aid in the regeneration of tooth support, lost due to periodontal disease or trauma, and to regenerate bone defects around implants and at sites intended for implant placement, by acting as a barrier to prevent the down-growth of soft tissue into the underlying bone during the healing period. It is a pliable material made of animal-derived collagen (e.g., porcine) which may be fixed to soft tissues with sutures; it is applied between soft tissue and bone during periodontal flap surgery and applied to grafted bone defects in guided bone regeneration (GBR) and guided tissue regeneration (GTR) procedures. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Regulatory Flags#

DUNS number
176262442
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813954023915OssiMend Bioactive MoldableMCCBA05032020-09-15
00813954022901OssiMend Bioactive MoldableMCCBA0252019-08-22
00813954022918OssiMend Bioactive MoldableMCCBA052019-08-22
00813954022925OssiMend Bioactive MoldableMCCBA05062019-08-22
00813954022932OssiMend Bioactive MoldableMCCBA10062019-08-22
00813954022949OssiMend Bioactive MoldableMCCBA10122019-08-22
00813954022956OssiMend Bioactive MoldableMCCBA20122019-08-22
00813954022963OssiMend Bioactive MoldableMCCBA20252019-08-22
00813954022970OssiMend Bioactive MoldableMCCBA40252019-08-22
05060440334139NeoGen Collagen Flex640502019-06-24
05060440334146NeoGen Collagen Flex640512019-06-24
05060440334160NeoGen Collagen Firm640552019-06-24
05060440334177NeoGen Collagen Firm640562019-06-24
05060440334184NeoGen Collagen Firm640572019-06-24
10813954024261OsteoMaxx PlugXA6252021-07-26
10813954024278OsteoMaxx PlugXA1202021-07-26
00813954020433Zimmer Collagen Tape0100Z2015-10-23
00813954020440Zimmer Collagen Patch0101Z2015-10-23
00813954020457Zimmer Collagen Plug0102Z2015-10-23
00813954029078PLENA FLEXCDMPP3040CDMPP30402026-10-13

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Primary DI, Brand, Company table
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00810179632366DynaMatrix PlusCOOK BIOTECH INCORPORATEDNPL2026-07-31
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00810179632892DynaMatrixCOOK BIOTECH INCORPORATEDNPL2026-07-31
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07610221017669Bionnovation Gide XPGeistlich Pharma AGNPL2026-05-08
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09421907331720Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331744Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331799Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331805Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331812Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331836Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
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