Identity
- Trade Name
- MBCP FDA UDI
- Generic Name
- Bone matrix implant, synthetic, non-antimicrobial FDA UDI
- Device Name
- Synthetic Bone Substitute Cylinder FDA UDI
- Model / Reference
- 0410D01 FDA UDI
- Description
- Synthetic Bone Substitute Cylinder FDA UDI
Identifiers
- Catalog Number
- 0410D01 FDA UDI
- Primary DI / UDI-DI
- 03700501800235 FDA UDI
- 510(k) Number
- FDA Product Code
- MQV FDA 510(k)FDA UDI
- GMDN Term
- Bone matrix implant, synthetic, non-antimicrobial FDA UDI
Classification
- Device Class
- Class II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 888.3045 FDA 510(k)
- Regulation Number
- 888.3045 FDA 510(k)FDA UDI
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Length — 20 Millimeter FDA UDI
MBCP is a biphasic calcium phosphate synthetic bone graft substitute with a unique micro and macroporous structure that most closely resembles the architecture of natural human bone. It is soluble and resorbable, gradually dissolving in the body to promote new bone formation through the release of calcium and phosphate ions.
MBCP is supplied as a synthetic bone graft substitute for use in bone regeneration. It is intended for dental applications and is regulated under FDA 510K clearance with product code MQV. The device is manufactured by Biomatlante and has model number K051774.
Frequently asked questions
What is MBCP used for in dental applications?
MBCP is a synthetic bone graft substitute designed for bone regeneration in dental applications. Its unique micro and macroporous structure closely resembles natural human bone, promoting new bone formation through the release of calcium and phosphate ions as it gradually dissolves in the body.
How is MBCP supplied and what are its key characteristics?
MBCP is supplied as a synthetic bone graft substitute with a unique micro and macroporous structure that most closely resembles natural human bone architecture. It is soluble and resorbable, gradually dissolving in the body to facilitate bone regeneration through the release of calcium and phosphate ions.
What is the regulatory status of MBCP?
MBCP is regulated under FDA 510K clearance with product code MQV. It has model number K051774 and was manufactured by Biomatlante. The device received traditional clearance with a decision code of SESE (Substantially Equivalent) in 2006.
Is MBCP a single-use device or can it be reused?
The device data does not specify whether MBCP is single-use or reusable. As a synthetic bone graft substitute intended for bone regeneration in dental applications, it would typically be used in a single procedure, but specific reuse information is not provided in the available data.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: MBCP® - Synthetic Bone Substitute - Biomatlante, Biologics Solutions - Biomatlante, Biomatlante MBCP Synthetic Bone Graft Substitute, Synthetic bone substitute - MBCP® - Biomatlante - for dental sugery ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K051774 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomatlante
Sources (2)
- FDA 510(k) K051774 24 fields · synced Sep 27, 2026
- FDA UDI 11c70451-b4e7-464f-abc3-d417e08a7695 37 fields · synced May 27, 2026