FDA.reportPublic FDA data

Xymphony Contour Adapting Resorbable Membrane

Primary DI
00812337027021
Brand
Xymphony Contour Adapting Resorbable Membrane
Company
DSM BIOMEDICAL, INC.
Model
30071-02
Catalog number
XYMPHONY-20x30
Published
2016-06-22
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
00812337027021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812337027021008123370270218123370270210812337027021

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
Length20Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
131107757
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
00812337020695Medeor Tendon Matrix30006-012026-03-24
00812337020701Medeor Tendon Matrix30006-022026-03-24
00812337020794Meso Tendon Matrix30054-012026-03-24
00812337020800Meso Tendon Matrix30054-022026-03-24
00812337020817Meso Tendon Matrix30054-032026-03-24
00812337020824Meso Tendon Matrix30054-042026-03-24
00812337020671Meso BioMatrix® Acellular Peritoneum Matrix 30063-079101622025-03-14
00812337020688Meso BioMatrix® Acellular Peritoneum Matrix 30063-089102202025-03-14
00812337020541Resolve Matrix™ Biologic Membrane30052-26RMAD222023-12-18
00812337020558Resolve Matrix™ Biologic Membrane30052-27RMAD242023-12-18
00812337020565Resolve Matrix™ Biologic Membrane30052-28RMAD452023-12-18
00812337020572Resolve Matrix™ Biologic Membrane30052-29RMAD682023-12-18
00812337020589Resolve Matrix™ Biologic Membrane30052-30RMAD232023-12-18
00812337020596Resolve Matrix™ Biologic Membrane30052-31RMAD342023-12-18
00812337020602xenoPATCH™30052-32XPM552023-12-12
M263W25000WizardBio Resorbable Calcium Phosphate Cement21004-05W250002019-01-02
00812337020442Drillable Bone Void Filler21005-0307.705.003S2023-01-11
00812337020459Drillable Bone Void Filler21005-0507.705.005S2023-01-11
00812337020466Drillable Bone Void Filler21005-1007.705.010S2023-01-11
M26300110301005CopiOs® Bone Void Filler Sponge20101-0200-1103-010-052015-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00813954028590bioMAINTAINCOLLAGEN MATRIX, INC.NPL2026-03-23
00813954028606bioMAINTAINCOLLAGEN MATRIX, INC.NPL2026-03-23
00813954028613bioMAINTAINCOLLAGEN MATRIX, INC.NPL2026-03-23
00813954028453Tissue Specialists Resorbable Collagen MembraneCOLLAGEN MATRIX, INC.NPL2026-03-09
00813954028460Tissue Specialists Resorbable Collagen MembraneCOLLAGEN MATRIX, INC.NPL2026-03-09
00813954028477Tissue Specialists Resorbable Collagen MembraneCOLLAGEN MATRIX, INC.NPL2026-03-09
00813954027470RCM6COLLAGEN MATRIX, INC.NPL2026-01-07
00813954027487RCM6COLLAGEN MATRIX, INC.NPL2026-01-07
00813954027494RCM6COLLAGEN MATRIX, INC.NPL2026-01-07
00813954027852conFORMCOLLAGEN MATRIX, INC.NPL2026-01-07
00813954027869conFORMCOLLAGEN MATRIX, INC.NPL2026-01-07
00813954027876conFORMCOLLAGEN MATRIX, INC.NPL2026-01-07
00813954028019bioADAPTCOLLAGEN MATRIX, INC.NPL2026-01-07
00813954028026bioADAPTCOLLAGEN MATRIX, INC.NPL2026-01-07
00813954028033bioADAPTCOLLAGEN MATRIX, INC.NPL2026-01-07
00813954028040bioADAPTCOLLAGEN MATRIX, INC.NPL2026-01-07
00813954028057bioADAPTCOLLAGEN MATRIX, INC.NPL2026-01-07
00813954028064bioADAPTCOLLAGEN MATRIX, INC.NPL2026-01-07
00813954028071Bicon Resorbable Collagen MembraneCOLLAGEN MATRIX, INC.NPL2026-01-06
00813954028088Bicon Resorbable Collagen MembraneCOLLAGEN MATRIX, INC.NPL2026-01-06
00813954028095Bicon Resorbable Collagen MembraneCOLLAGEN MATRIX, INC.NPL2026-01-06
00813954028323bioMAINTAINCOLLAGEN MATRIX, INC.NPL2026-01-06
00813954028330bioMAINTAINCOLLAGEN MATRIX, INC.NPL2026-01-06
00813954028347bioMAINTAINCOLLAGEN MATRIX, INC.NPL2026-01-06
00813954028354bioMAINTAINCOLLAGEN MATRIX, INC.NPL2026-01-06
00813954028361bioMAINTAINCOLLAGEN MATRIX, INC.NPL2026-01-06
00813954028378bioMAINTAINCOLLAGEN MATRIX, INC.NPL2026-01-06
00841336110984Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNPL2025-09-28
00841336111028Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNPL2025-09-28
00841336111080Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNPL2025-09-28