FDA.reportPublic FDA data

Geistlich Fibro-Gide®

Primary DI
07610221011612
Brand
Geistlich Fibro-Gide®
Company
Geistlich Pharma AG
Model
500273
Published
2017-12-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171050000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171050000Geistlich Fibro-GideGeistlich Pharma AG2017-11-09NPL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07610221011612PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07610221011612076102210116127610221011612

GMDN Terms#

Term, Definition table
TermDefinition
Dental soft-tissue matrix implant, animal-derivedA sterile bioabsorbable material intended to be used to aid in the regeneration of oral soft tissue, lost due to periodontal disease or trauma, primarily through promotion of new blood vessels; it is indicated for various oral soft tissue augmentation procedures (e.g. alveolar ridge reconstruction, localized gingival augmentation, covering of recession defects and extraction sockets). 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 to soft tissue by properly prepared flaps during periodontal flap surgery and guided tissue regeneration (GTR) surgical procedures. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth6Millimeter
Height40Millimeter
Width20Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
480781728
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07610221017737Derma-Gide®5020102026-06-01
07610221017829Device 300423 Granules5021902026-06-01
07610221017836Device 300423 Granules5021912026-06-01
07610221017843Device 300423 Granules5021922026-06-01
07610221017850Device 300423 Granules5021932026-06-01
07610221017867Device 300423 Granules5021942026-06-01
07610221017874Device 300423 Granules5021952026-06-01
07610221017881Device 300423 Granules5021962026-06-01
07610221017898Device 300423 Granules5021972026-06-01
07610221017904Device 300423 Granules5021982026-06-01
07610221017911Device 300423 Granules5021992026-06-01
07610221017928Device 300423 Granules5022002026-06-01
07610221017645Bionnovation Gide XP5021702026-05-08
07610221017652Bionnovation Gide XP5021712026-05-08
07610221017669Bionnovation Gide XP5021722026-05-08
07610221017201Geistlich Bio-Gide®5021132026-04-09
07610221017126Derma-Gide®5004272025-07-01
07610221017133Derma-Gide®5004742025-07-01
07610221017140Derma-Gide®5004802025-07-01
07610221015481Geistlich Fibro-Gide®5008382022-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810179632311DynaMatrix PlusCOOK BIOTECH INCORPORATEDNPL2026-07-31
00810179632328DynaMatrix PlusCOOK BIOTECH INCORPORATEDNPL2026-07-31
00810179632359DynaMatrix PlusCOOK BIOTECH INCORPORATEDNPL2026-07-31
00810179632366DynaMatrix PlusCOOK BIOTECH INCORPORATEDNPL2026-07-31
00810179632373DynaMatrix PlusCOOK BIOTECH INCORPORATEDNPL2026-07-31
00810179632878DynaMatrixCOOK BIOTECH INCORPORATEDNPL2026-07-31
00810179632885DynaMatrixCOOK BIOTECH INCORPORATEDNPL2026-07-31
00810179632892DynaMatrixCOOK BIOTECH INCORPORATEDNPL2026-07-31
00810179632908DynaMatrixCOOK BIOTECH INCORPORATEDNPL2026-07-31
00810179632915DynaMatrixCOOK BIOTECH INCORPORATEDNPL2026-07-31
00810179632922DynaMatrixCOOK BIOTECH INCORPORATEDNPL2026-07-31
07610221017645Bionnovation Gide XPGeistlich Pharma AGNPL2026-05-08
07610221017652Bionnovation Gide XPGeistlich Pharma AGNPL2026-05-08
07610221017669Bionnovation Gide XPGeistlich Pharma AGNPL2026-05-08
09421907331614Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331621Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331638Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331652Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331706Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331713Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
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
06974944921339NeocirrusNeo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.NPL2026-04-16
06974944921346NeocirrusNeo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.NPL2026-04-16
06974944921353NeocirrusNeo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.NPL2026-04-16