Identity
- Trade Name
- Zuga FDA UDI
- Generic Name
- Pin/post dental drill bit FDA UDI
- Device Name
- Twist Drill 3.50mm x 15mm FDA UDI
- Model / Reference
- TWD-350-015 FDA UDI
- Description
- Twist Drill 3.50mm x 15mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00853095004596 FDA UDI
- 510(k) Number
- K122664 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Pin/post dental drill bit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3640 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
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: Pin/post dental drill bit
Zuga by Zuga Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pin/post dental drill bit.
- MACRO-LOCK OVAL INTRO KIT A — RECHERCHES TECHNIQUES DENTAIRES · Class I
- KOMET Intraoral dental drill for root posts — Gebr. Brasseler GmbH & Co. KG · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class I
- MACRO-LOCK FINISHING DRILL 3 — RECHERCHES TECHNIQUES DENTAIRES · Class I
- Essential Gates Glidden Drills — ESSENTIAL DENTAL SYSTEMS, INC. · Class I
- GLASS FIBRE POST — Cynosure, LLC · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class I
- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
Cleared under the same submission
K122664 also covers:
- Zuga — Zuga Medical, Inc.
- Zuga — Zuga Medical, Inc.
- Zuga — Zuga Medical, Inc.
- Zuga — Zuga Medical, Inc.
- Zuga — Zuga Medical, Inc.
- Zuga — Zuga Medical, Inc.
- Zuga — Zuga Medical, Inc.
- Zuga — Zuga Medical, Inc.
- Zuga — Zuga Medical, Inc.
- Zuga — Zuga Medical, Inc.
- Zuga — Zuga Medical, Inc.
- Zuga — Zuga Medical, Inc.
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
- Zuga Medical, Inc.
Sources (1)
- FDA UDI 892d9314-a4eb-4fca-b976-ebe8272818ee 35 fields · synced May 30, 2026