FDA.reportPublic FDA data

SalvinOSS Collagen Xenograft and Collagen Bone Graft Material

Primary DI
00812337020275
Brand
SalvinOSS Collagen Xenograft and Collagen Bone Graft Material
Company
DSM BIOMEDICAL, INC.
Model
30069-01
Device description
Porcine Anorganic Dental Bone Graft with Bovine Collagen
Published
2021-01-15
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
NPMBone Grafting Material, Animal Source

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NPMBone Grafting Material, Animal SourceDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193212000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193212000DSM Biomedical Dental Bone Graft PlusDsm Biomedical2020-09-10NPM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812337020275PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812337020275008123370202758123370202750812337020275

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Weight100Milligram

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
131107757
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812337020039XCM Biologic® Tissue Matrix 30010-03XM106.0204S2015-09-17
00812337020046XCM Biologic® Tissue Matrix 30010-04XM106.0307S2015-09-17
00812337020060XCM Biologic® Tissue Matrix30010-06XM106.0407S2015-09-17
00812337020084XCM Biologic® Tissue Matrix 30010-08XM106.0416S2015-09-17
00812337020091XCM Biologic® Tissue Matrix30010-09XM106.0420S2015-09-17
00812337020114XCM Biologic® Tissue Matrix30010-11XM106.0516S2015-09-17
00812337020138XCM Biologic® Tissue Matrix30010-13XM106.0612S2015-09-17
00812337020145XCM Biologic® Tissue Matrix30010-14XM106.0616S2015-09-17
00812337020152XCM Biologic® Tissue Matrix30010-15XM106.0620S2015-09-17
00812337020190XCM Biologic® Tissue Matrix 30010-19XM106.0812S2015-09-17
00812337020206XCM Biologic® Tissue Matrix30010-20XM106.0816S2015-09-17
00812337020213XCM Biologic® Tissue Matrix30010-21XM106.0820S2015-09-17
00812337020220XCM Biologic® Tissue Matrix30010-22XM106.1016S2015-09-17
00812337020237XCM Biologic® Tissue Matrix30010-23XM106.1020S2015-09-17
00812337020251XCM Biologic® Tissue Matrix30010-25XM106.1220S2015-09-17
00812337020268XCM Biologic® Tissue Matrix 30010-26XM106.1620S2015-09-17
00812337020299XCM Biologic® Tissue Matrix30010-29XM106.1625S2015-09-17
00812337020305XCM Biologic® Tissue Matrix30010-30XM106.2020S2015-09-17
00812337020312XCM Biologic® Tissue Matrix30010-31XM106.2025S2015-09-17
00812337020329XCM Biologic® Tissue Matrix30010-32XM106.2030S2015-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806387896760Renew-Cera, (BoneMedik-DM 0.3~0.5mm, 0.25g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896777Renew-Cera, (BoneMedik-DM 0.5~1.0 mm, 0.25g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896784Renew-Cera, (BoneMedik-DM 1.0~2.0 mm, 0.25g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896791Renew-Cera, (BoneMedik-DM 0.3~0.5 mm, 0.50g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896807Renew-Cera, (BoneMedik-DM 0.5~1.0 mm, 0.50g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896814Renew-Cera, (BoneMedik-DM 1.0~2.0 mm, 0.50g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896821Renew-Cera, (BoneMedik-DM 0.3~0.5 mm, 1.0g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896838Renew-Cera, (BoneMedik-DM 0.5~1.0mm, 1.0g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896845Renew-Cera, (BoneMedik-DM 1.0~2.0 mm, 1.0g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896852Renew-Cera, (BoneMedik-DM 0.3 ~ 0.5 mm, 2.0g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896869Renew-Cera, (BoneMedik-DM 0.5~1.0 mm, 2.0g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896876Renew-Cera, (BoneMedik-DM 1.0~2.0 mm, 2.0g)Meta Biomed Co., Ltd.NPM2022-09-20
08800039000000THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000017THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000024THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000031THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000048THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000055THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000062THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000079THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000086THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000093THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000109THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000116THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000123THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000130THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000147THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000154THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000161THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000178THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15