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Regeneross®

FDA UDI

Class II (US FDA UDI)

by Biomet 3i, Llc

Identity

Trade Name
REGENEROSS® FDA UDI
Generic Name
Dental bone matrix implant, human-derived FDA UDI
Device Name
DEMINERALIZED BONE MATRIX (DMB) 2.0CC FDA UDI
Model / Reference
ROAP20 FDA UDI
Description
DEMINERALIZED BONE MATRIX (DMB) 2.0CC FDA UDI

Identifiers

Primary DI / UDI-DI
00844868035510 FDA UDI
FDA Product Code
NUN FDA UDI
GMDN Term
Dental bone matrix implant, human-derived 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

Yes

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Dental bone matrix implant, human-derived

Regeneross® by Biomet 3i, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental bone matrix implant, human-derived.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biomet 3i, Llc

Sources (1)

  • FDA UDI 1c816f24-12e8-4391-b020-c49a942d58f5 35 fields · synced May 30, 2026