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cerabone®

FDA UDI

Class II (US FDA UDI)

by Botiss Biomaterials GmbH

Identity

Trade Name
cerabone® FDA UDI
Generic Name
Dental bone matrix implant, animal-derived FDA UDI
Device Name
Bovine Bone Grafting Material For Filling Bone Defects FDA UDI
Model / Reference
MEUS-1522 FDA UDI
Description
Bovine Bone Grafting Material For Filling Bone Defects FDA UDI

Identifiers

Catalog Number
MEUS-1522 FDA UDI
Primary DI / UDI-DI
04260396252179 FDA UDI
FDA Product Code
NPM FDA UDI
GMDN Term
Dental bone matrix implant, animal-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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

No

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
MRI Safety
MR Safe FDA UDI

Dimensions & Sizes

Size
Total Volume — 2 Milliliter FDA UDI

Category: Dental bone matrix implant, animal-derived

cerabone® by Botiss Biomaterials GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 3c08ff60-ed80-4180-bf57-d550fc4b408e 37 fields · synced May 31, 2026