FDA.reportPublic FDA data

Bionnovation Gide XP

Primary DI
07610221017669
Brand
Bionnovation Gide XP
Company
Geistlich Pharma AG
Model
502172
Published
2026-05-08
Public version status
New
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07610221017669PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07610221017669076102210176697610221017669

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
Height40Millimeter
Width30Millimeter

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
07610221017645Bionnovation Gide XP5021702026-05-08
07610221017652Bionnovation Gide XP5021712026-05-08
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
07610221015498Geistlich Fibro-Gide®5008392022-09-09
07610221011605Geistlich Fibro-Gide®5002722017-12-15
07610221011612Geistlich Fibro-Gide®5002732017-12-15
07610221015252Geistlich Bio-Gide® Forte5020752025-10-01
07610221015269Geistlich Bio-Gide® Forte5020762025-10-01
07610221015283Geistlich Bio-Gide® Forte5020782025-10-01
07610221015290Geistlich Bio-Gide® Forte 5020792025-10-01
07610221010141SwissGraft X D-Line5020802025-08-01
07610221010158SwissGraft X D-Line5020812025-08-01
07610221010219SwissMembrane X D-Line5020882025-08-01
07610221010257SwissMembrane X D-Line5020892025-08-01
07610221015375SwissGraft X D-Line5020822025-08-01
07610221015382SwissGraft X D-Line5020832025-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07610221017645Bionnovation Gide XPGeistlich Pharma AGNPL2026-05-08
07610221017652Bionnovation 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
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06974944921742NeocirrusNeo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.NPL2026-04-16
06974944921759NeocirrusNeo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.NPL2026-04-16
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