OSSIX™ Bone

FDA UDI

Class II (US FDA UDI)

by Datum Dental Ltd

Identity

Trade Name: OSSIX™ Bone FDA UDI
Generic Name: Dental bone matrix implant, synthetic FDA UDI
Device Name: OSSIX™ BONE is a biodegradable, osteoconductive, and biocompatible bone grafting material intended for guided tissue and bone regeneration. The OSSIX™ BONE matrix is composed of 80% synthetic crystalline non-sintered hydroxylapatite and 20% collagen, which is derived from veterinary certified pigs and is purified and cross-linked. FDA UDI
Model / Reference: 0.500 cc FDA UDI
Description: OSSIX™ BONE is a biodegradable, osteoconductive, and biocompatible bone grafting material intended for guided tissue and bone regeneration. The OSSIX™ BONE matrix is composed of 80% synthetic crystalline non-sintered hydroxylapatite and 20% collagen, which is derived from veterinary certified pigs and is purified and cross-linked. FDA UDI

Identifiers

Catalog Number: OXB0500 FDA UDI
Primary DI / UDI-DI: 07290015477253 FDA UDI
FDA Product Code: NPM FDA UDI
GMDN Term: Dental bone matrix implant, synthetic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3930 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

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Serial Number

FDA UDI

Expiration Date

Yes

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Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Height — 5 Millimeter FDA UDI
Length — 10 Millimeter FDA UDI
Depth — 10 Millimeter FDA UDI

Category: Dental bone matrix implant, synthetic

OSSIX™ Bone by Datum Dental Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Datum Dental Ltd

Sources (1)

FDA UDI c067d4f9-9125-47e3-8761-46c396c53e82 36 fields · synced Jun 8, 2026