FDA.reportPublic FDA data

Salvin Dental Specialties

Primary DI
00841336125759
Brand
Salvin Dental Specialties
Company
SALVIN DENTAL SPECIALTIES, LLC
Model
SALVINOSS-COLL-250MG
Catalog number
SALVINOSS-COLL-250MG
Device description
250mg SalvinOss with Collagen
Published
2024-12-11
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
NPMBONE GRAFTING MATERIAL, ANIMAL SOURCE

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841336125759PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841336125759008413361257598413361257590841336125759

GMDN Terms#

Term, Definition table
TermDefinition
Dental bone void filling material, animal-derivedA bioabsorbable, implantable device made primarily of animal-derived materials (e.g., bovine, porcine) intended to replace maxillofacial and/or mandibular bone lost through trauma or dental surgery. Also referred to as a graft, matrix, or void filler, it typically provides an osteoconductive scaffold that promotes bone growth, and is used to fill bone cavities and defects. It is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable materials.

Regulatory Flags#

DUNS number
113344790
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
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841336111905Allo-3D-PlusALLO-3D-PLUS-1.0ALLO-3D-PLUS-1.02024-07-11
00841336111912Allo-3D-PlusALLO-3D-PLUS-2.0ALLO-3D-PLUS-2.02024-07-11
00841336138766Salvin Dental SpecialtiesOFIBER-0.5CCOFIBER-0.5CC2025-09-28
00841336138773Salvin Dental SpecialtiesOFIBER-1.0CCOFIBER-1.0CC2025-09-28
00841336138797Salvin Dental SpecialtiesOFIBER-PLUS-0.5CCOFIBER-PLUS-0.5CC2025-09-28
00841336138803Salvin Dental SpecialtiesOFIBER-PLUS-1.0CCOFIBER-PLUS-1.0CC2025-09-28
00841336114395Salvin Dental SpecialtiesDEMIN-CORT-L-5.0DEMIN-CORT-L-5.02024-12-11
00841336125704Salvin Dental SpecialtiesSALVINOSS-0.5SALVINOSS-0.52024-12-11
00841336125711Salvin Dental SpecialtiesSALVINOSS-1.0SALVINOSS-1.02024-12-11
00841336125728Salvin Dental SpecialtiesSALVINOSS-2.5SALVINOSS-2.52024-12-11
00841336125735Salvin Dental SpecialtiesSALVINOSS-COLL-100MGSALVINOSS-COLL-100MG2024-12-11
00841336136229Salvin Dental SpecialtiesMIN-CAN-2.00MIN-CAN-2.002024-12-11
00841336138780Salvin Dental SpecialtiesOFIBER-2.5CCOFIBER-2.5CC2024-12-11
00841336111929SALVINOSS-BSALVINOSS-B-0.52024-05-27
00841336111936SALVINOSS-BSALVINOSS-B-1.02024-05-27
00841336111943SALVINOSS-BSALVINOSS-B-2.02024-05-27
00841336111950SALVINOSS-BSALVINOSS-B-4.02024-05-27
00841336111998SALVINOSS-BSALVINOSS-B-SYR-0.252024-05-27
00841336112001SALVINOSS-BSALVINOSS-B-SYR-0.502024-05-27
00841336112018SALVINOSS-BSALVINOSS-B-SYR-1.002024-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00813954026787SynOss PlugCOLLAGEN MATRIX, INC.NPM2025-09-05
00813954026794SynOss PlugCOLLAGEN MATRIX, INC.NPM2025-09-05
00813954027005PLENA Graft 0.5cc SyringeCOLLAGEN MATRIX, INC.NPM2025-08-01
00813954027012PLENA Graft 0.5COLLAGEN MATRIX, INC.NPM2025-07-15
00813954026732PuraFILLCOLLAGEN MATRIX, INC.NPM2025-03-26
00813954026749PuraFILLCOLLAGEN MATRIX, INC.NPM2025-03-26
00813954026183REGENAFILLCOLLAGEN MATRIX, INC.NPM2024-06-21
00813954026190REGENAFILLCOLLAGEN MATRIX, INC.NPM2024-06-21
00813954026138EvoBone PlugCOLLAGEN MATRIX, INC.NPM2024-03-28
00813954026145EvoBone PlugCOLLAGEN MATRIX, INC.NPM2024-03-28
00614950028443OUSIA bioXENACE SURGICAL SUPPLY CO., INC.NPM2023-06-15
00614950028450OUSIA bioXENACE SURGICAL SUPPLY CO., INC.NPM2023-06-15
00614950028467OUSIA bioXENACE SURGICAL SUPPLY CO., INC.NPM2023-06-15
00614950028474OUSIA bioXENACE SURGICAL SUPPLY CO., INC.NPM2023-06-15
00614950028481OUSIA bioXENACE SURGICAL SUPPLY CO., INC.NPM2023-06-15
00614950028498OUSIA bioXENACE SURGICAL SUPPLY CO., INC.NPM2023-06-15
00614950028504OUSIA bioXENACE SURGICAL SUPPLY CO., INC.NPM2023-06-15
00614950028511OUSIA bioXENACE SURGICAL SUPPLY CO., INC.NPM2023-06-15
00813954025315RegenerOssCOLLAGEN MATRIX, INC.NPM2023-01-06
00813954025322RegenerOssCOLLAGEN MATRIX, INC.NPM2023-01-06
00614950027934MinerOss® XACE SURGICAL SUPPLY CO., INC.NPM2022-10-27
00614950027941MinerOss® XACE SURGICAL SUPPLY CO., INC.NPM2022-10-27
00614950027958MinerOss® XACE SURGICAL SUPPLY CO., INC.NPM2022-10-27
00614950027965MinerOss® XACE SURGICAL SUPPLY CO., INC.NPM2022-10-27
00614950027972MinerOss® XACE SURGICAL SUPPLY CO., INC.NPM2022-10-27
00614950027989MinerOss® XACE SURGICAL SUPPLY CO., INC.NPM2022-10-27
00614950027996MinerOss® XACE SURGICAL SUPPLY CO., INC.NPM2022-10-27
00614950028009MinerOss® XACE SURGICAL SUPPLY CO., INC.NPM2022-10-27
00614950028016MinerOss® XACE SURGICAL SUPPLY CO., INC.NPM2022-10-27
00614950028023MinerOss® XACE SURGICAL SUPPLY CO., INC.NPM2022-10-27