FDA.report

SALVIN FULFILL

Primary DI
00813954024677
Brand
SALVIN FULFILL
Company
COLLAGEN MATRIX, INC.
Model
FULFILL-6x25-PKG-5
Device description
Socket Preservation Plug 6mm x 25mm
Published
2022-03-07
Public version status
New
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
10813954024674PrimaryGS10
00813954024677Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081395402467410813954024674
00813954024677008139540246778139540246770813954024677

GMDN Terms

TermDefinition
Dental bone matrix implant, syntheticA sterile bioabsorbable device made of synthetic material 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 typically made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), sometimes bioactive glasses or bioabsorbable polymers, and used to fill bone cavities and defects to 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
Device Size Text, specify0

Sterilization Methods

Method

Regulatory Flags

DUNS number
176262442
Device count
5
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

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00813954028590bioMAINTAINOUSA1EUOUSA1EU2026-03-23
00813954028606bioMAINTAINOUSA2EUOUSA2EU2026-03-23
00813954028613bioMAINTAINOUSA3EUOUSA3EU2026-03-23
00813954028484XENOFY-PXFP-050050XFP-0500502026-03-12
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00813954028453Tissue Specialists Resorbable Collagen MembraneT5096000T50960002026-03-09
00813954028460Tissue Specialists Resorbable Collagen MembraneT5093000T50930002026-03-09
00813954028477Tissue Specialists Resorbable Collagen MembraneT5098000T50980002026-03-09

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