FDA.report

SalvinOSS™ Xenograft Bone Graft Material

Primary DI
00812337027045
Brand
SalvinOSS™ Xenograft Bone Graft Material
Company
DSM BIOMEDICAL, INC.
Model
30070-01
Catalog number
SALVINOSS-0.50
Device description
Porcine Anorganic Dental Bone Graft
Published
2017-05-19
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

Related Records

Product Codes

CodeName
NPMBone Grafting Material, Animal Source

Product Code Classifications

CodeDeviceSpecialtyClass
NPMBone Grafting Material, Animal SourceDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00812337027045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00812337027045008123370270458123370270450812337027045

GMDN Terms

TermDefinition
Dental bone matrix implant, animal-derivedA sterile bioabsorbable device made primarily of animal-derived bone or dentin matrix (e.g., bovine, porcine) implanted into the body to provide osteoconductive bone-tissue scaffolds to replace maxillofacial and/or mandibular bone lost through trauma or dental surgery. It is used to fill bone cavities and defects and contains pores that promote the ingrowth of endogenous bone for skeletal reconstruction and/or augmentation. It is typically provided as sterile cancellous blocks, chips, or granules of varying sizes, or mouldable materials.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

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
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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 DIBrandCompanyProduct codePublished
00813954028484XENOFY-PCOLLAGEN MATRIX, INC.NPM2026-03-12
00813954028491XENOFY-PCOLLAGEN MATRIX, INC.NPM2026-03-12
00813954028507XENOFY-PCOLLAGEN MATRIX, INC.NPM2026-03-12
00813954028514XENOFY-PCOLLAGEN MATRIX, INC.NPM2026-03-12
00813954028521XENOFY-PCOLLAGEN MATRIX, INC.NPM2026-03-12
00813954028538XENOFY-PCOLLAGEN MATRIX, INC.NPM2026-03-12
08809490621878OCTABONECHIYEWON.LTDNPM2026-02-02
08809490621885OCTABONECHIYEWON.LTDNPM2026-02-02
08809490621892OCTABONECHIYEWON.LTDNPM2026-02-02
08809490621908OCTABONECHIYEWON.LTDNPM2026-02-02
08809490621977OCTABONECHIYEWON.LTDNPM2026-02-02
08809490621984OCTABONECHIYEWON.LTDNPM2026-02-02
08809490621946TI-OSSCHIYEWON.LTDNPM2026-01-28
08809490621953TI-OSSCHIYEWON.LTDNPM2026-01-28
00813954027739NuOssCOLLAGEN MATRIX, INC.NPM2026-01-07
00813954027746NuOssCOLLAGEN MATRIX, INC.NPM2026-01-07
00813954027753NuOssCOLLAGEN MATRIX, INC.NPM2026-01-07
00813954027760NuOssCOLLAGEN MATRIX, INC.NPM2026-01-07
00813954027777NuOssCOLLAGEN MATRIX, INC.NPM2026-01-07
00813954027784NuOssCOLLAGEN MATRIX, INC.NPM2026-01-07
00813954027791NuOssCOLLAGEN MATRIX, INC.NPM2026-01-07
00813954027807NuOssCOLLAGEN MATRIX, INC.NPM2026-01-07
00813954027814NuOssCOLLAGEN MATRIX, INC.NPM2026-01-07
00813954027821NuOssCOLLAGEN MATRIX, INC.NPM2026-01-07
00813954027913MinerOss X CollagenCOLLAGEN MATRIX, INC.NPM2026-01-07
00813954027920MinerOss X CollagenCOLLAGEN MATRIX, INC.NPM2026-01-07
00813954027937MinerOss X CollagenCOLLAGEN MATRIX, INC.NPM2026-01-07
00813954027944NuOss CollagenCOLLAGEN MATRIX, INC.NPM2026-01-07
00813954027951NuOss CollagenCOLLAGEN MATRIX, INC.NPM2026-01-07
00813954027968NuOss CollagenCOLLAGEN MATRIX, INC.NPM2026-01-07