Identity
- Trade Name
- MEITAC FDA UDI
- Generic Name
- Craniofacial bone tack, non-bioabsorbable FDA UDI
- Device Name
- The system MEITAC consist of Tacs and neccessary accessories. The system contains 20 Tacs. Tacs are used for the fixation of membranes (resorbable membranes nonresorbable membranes) to the bone structure. Tacs are intended for single use only. The Tacs consist of titanium alloy Grade 5 and are delivered non sterile. FDA UDI
- Model / Reference
- BMPBA FDA UDI
- Description
- The system MEITAC consist of Tacs and neccessary accessories. The system contains 20 Tacs. Tacs are used for the fixation of membranes (resorbable membranes nonresorbable membranes) to the bone structure. Tacs are intended for single use only. The Tacs consist of titanium alloy Grade 5 and are delivered non sterile. FDA UDI
Identifiers
- Catalog Number
- BMPBA FDA UDI
- Primary DI / UDI-DI
- E0HM79MT0019 FDA UDI
- 510(k) Number
- K130682 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
Yes
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
Meitac by Hager & Meisinger Gesellschaft mit beschränkter Haftung — 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
- MCBio Supertack Tack 3mm - N.10 — MC BIO SRL · Class II
- MCBio Supertack Tack 5mm - N.5 — MC BIO SRL · Class II
- TACK-3-PT — SALVIN DENTAL SPECIALTIES, LLC · Class II
- MCBio Supertack Tack 4mm - N.5 — MC BIO SRL · Class II
- MCBio Supertack Tack 3mm - N.5 — MC BIO SRL · Class II
- Pin, dental — Hager & Meisinger Gesellschaft mit beschränkter Haftung · Class II
- Tac, dental — Hager & Meisinger Gesellschaft mit beschränkter Haftung · Class II
Cleared under the same submission
K130682 also covers:
- Bone Management — Hager & Meisinger Gesellschaft mit beschränkter Haftung
- Bone Management — Hager & Meisinger Gesellschaft mit beschränkter Haftung
- Master-Pin-Control — Hager & Meisinger Gesellschaft mit beschränkter Haftung
- Master-Pin-Control Basic — Hager & Meisinger Gesellschaft mit beschränkter Haftung
- Pin, dental — Hager & Meisinger Gesellschaft mit beschränkter Haftung
- Tac, dental — Hager & Meisinger Gesellschaft mit beschränkter Haftung
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
Sources (1)
- FDA UDI 87fcfd3f-1d2d-431d-aa5e-9b550a7450dc 36 fields · synced Jun 8, 2026