Identity
- Trade Name
- Bonck Tack FDA UDI
- Generic Name
- Dental regeneration membrane fixation tack, non-bioabsorbable FDA UDI
- Device Name
- Bonck Tack / DBT2505 FDA UDI
- Model / Reference
- DBT2505 FDA UDI
- Description
- Bonck Tack / DBT2505 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800053012171 FDA UDI
- 510(k) Number
- K222367 FDA UDI
- FDA Product Code
- DZL FDA UDI
- GMDN Term
- Dental regeneration membrane fixation 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
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Yes
FDA UDI
Category: Dental regeneration membrane fixation tack, non-bioabsorbable
Bonck Tack by Dentis Co. , Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K222367 also covers:
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
- Dentis Co. , Ltd
Sources (1)
- FDA UDI ed9b7dfc-2cd0-4758-b39b-94edd6667c71 34 fields · synced Jun 8, 2026