Bio | TCP Beta-Tricalcium Phosphate Porous Granulate

FDA UDI

Class II (US FDA UDI)

by Cytophil, Inc

Identity

Trade Name: Bio | TCP Beta-Tricalcium Phosphate Porous Granulate FDA UDI
Generic Name: Dental bone matrix implant, synthetic FDA UDI
Device Name: Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate indicated for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone. FDA UDI
Model / Reference: 04-010-01-BSB FDA UDI
Description: Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate indicated for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone. FDA UDI

Identifiers

Catalog Number: BTCP251 FDA UDI
Primary DI / UDI-DI: 00852108006299 FDA UDI
FDA Product Code: LYC 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

FDA UDI

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

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Total Volume — 1.0 Milliliter FDA UDI

Category: Dental bone matrix implant, synthetic

Bio | TCP Beta-Tricalcium Phosphate Porous Granulate by Cytophil, Inc — 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: Cytophil, Inc

Sources (1)

FDA UDI 8ea04307-8f96-43e8-8910-cafea981beb2 36 fields · synced May 30, 2026