Identity
- Trade Name
- MK Drill Bit FDA UDI
- Generic Name
- Pin/post dental drill bit FDA UDI
- Device Name
- MKDB-DG-08 * 10EA FDA UDI
- Model / Reference
- MKDB-DG-08 * 10set FDA UDI
- Description
- MKDB-DG-08 * 10EA FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800197900280 FDA UDI
- FDA Product Code
- QRQ FDA UDI
- GMDN Term
- Pin/post dental drill bit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
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: Pin/post dental drill bit
MK Drill Bit by M.K. Meditech Co. , Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Pin/post dental drill bit.
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- GLASS FIBRE POST — Cynosure, LLC · Class I
- Zuga — Zuga Medical, Inc. · 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 I | Pending data |
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Manufacturer
- Manufacturer
- M.K. Meditech Co. , Ltd.
Sources (1)
- FDA UDI d910f625-6051-487e-890b-5d471758602e 33 fields · synced May 31, 2026