FDA.reportPublic FDA data

Salvin Dental Specialties

Primary DI
00841336110984
Brand
Salvin Dental Specialties
Company
SALVIN DENTAL SPECIALTIES, LLC
Model
AMPLIFI-15x20
Catalog number
AMPLIFI-15x20
Device description
Salvin AMPLIFI Long Term Membrane - 15mm x 20mm
Published
2025-09-28
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
00841336110984PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841336110984008413361109848413361109840841336110984

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
113344790
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841336100886Salvin Dental SpecialtiesORAPLUG-PKG-10ORAPLUG-PKG-102020-02-28
00841336106413Salvin Dental SpecialtiesORBAN-1/2-SHORTORBAN-1/2-SHORT2026-06-08
00841336100480L-797BL-797B2015-10-30
00841336100381LV-493BLV-493B2018-02-22
00841336100473L-1180BL-1180B2015-10-30
00841013124457American Eagle InstrumentsAESSIRC2026-01-02
00841336104877Salvin Dental SpecialtiesGRAFT-SYR-2.8-CUGRAFT-SYR-2.8-CU2025-12-22
00841336104891Salvin Dental SpecialtiesGRAFTSYRINGE-STRGRAFTSYRINGE-STR2025-12-22
00841336104907Salvin Dental SpecialtiesGRAFT-SYR-S-CURVGRAFT-SYR-S-CURV2025-12-22
00841336104914Salvin Dental SpecialtiesGRAFT-SYR-S-STRGRAFT-SYR-S-STR2025-12-22
00841336106000Salvin Dental SpecialtiesGR11/12GR11/122025-12-22
00841336106062Salvin Dental SpecialtiesGRAFT-PACK-SERR-LGRAFT-PACK-SERR-L2025-12-22
00841336106079Salvin Dental SpecialtiesGRAFT-PACK-SERR-SGRAFT-PACK-SERR-S2025-12-22
00841336106239Salvin Dental SpecialtiesMEMB-CONDENSERMEMB-CONDENSER2025-12-22
00841336106499Salvin Dental SpecialtiesPIKOS-PACKERPIKOS-PACKER2025-12-22
00841336106697Salvin Dental SpecialtiesSINUS-DETACHSINUS-DETACH2025-12-22
00841336106802Salvin Dental SpecialtiesSUGARMAN-1S/2SSUGARMAN-1S/2S2025-12-22
00841336106819Salvin Dental SpecialtiesSUGARMAN-3S/4SSUGARMAN-3S/4S2025-12-22
00841336106918Salvin Dental SpecialtiesYG7/8YG7/82025-12-22
00841336108639Salvin Dental SpecialtiesIMPLA-SAFE-EXPLORERIMPLA-SAFE-EXPLORER2025-12-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810179632304DynaMatrix PlusCOOK BIOTECH INCORPORATEDNPL2026-07-31
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