Identity
- Trade Name
- MCBio Supertack Tack 3mm - N.5 FDA UDI
- Generic Name
- Craniofacial bone tack, non-bioabsorbable FDA UDI
- Device Name
- The MC Bio Supertack tacks are used for the stabilization of absorbable and non-absorbable membranes during the bone tissue regeneration and bone repair in the maxillofacial or mandibular area. The MC Bio Supertack system is designed to stabilize barrier membranes onto cortical plate bone, this may be used in maxillofacial or mandibular bone. General patient health, bone type and quality, and functional loads exerted should be considered and carefully evaluated prior to use. FDA UDI
- Model / Reference
- 9514010-5 FDA UDI
- Description
- The MC Bio Supertack tacks are used for the stabilization of absorbable and non-absorbable membranes during the bone tissue regeneration and bone repair in the maxillofacial or mandibular area. The MC Bio Supertack system is designed to stabilize barrier membranes onto cortical plate bone, this may be used in maxillofacial or mandibular bone. General patient health, bone type and quality, and functional loads exerted should be considered and carefully evaluated prior to use. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08056992093010 FDA UDI
- FDA Product Code
- DZL FDA UDI
- GMDN Term
- Craniofacial bone tack, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4880 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Craniofacial bone tack, non-bioabsorbable
MCBio Supertack Tack 3mm - N.5 by Mc Bio Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Craniofacial bone tack, non-bioabsorbable.
- TACK-5-PT — SALVIN DENTAL SPECIALTIES, LLC · Class II
- Pin, dental — Hager & Meisinger Gesellschaft mit beschränkter Haftung · Class II
- Tac, dental — Hager & Meisinger Gesellschaft mit beschränkter Haftung · Class II
- Bone Management — Hager & Meisinger Gesellschaft mit beschränkter Haftung · Class II
- MEITAC — Hager & Meisinger Gesellschaft mit beschränkter Haftung · Class II
- Master-Pin-Control Basic — Hager & Meisinger Gesellschaft mit beschränkter Haftung · Class II
- Master-Pin-Control — Hager & Meisinger Gesellschaft mit beschränkter Haftung · Class II
- TACK-3-PT — SALVIN DENTAL SPECIALTIES, LLC · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mc Bio Srl
Sources (1)
- FDA UDI 29fcfb75-289c-4484-bf59-b489de7ba826 33 fields · synced Jun 1, 2026