Identity
- Trade Name
- A. Titan Instruments FDA UDI
- Generic Name
- Dental drill bit extension FDA UDI
- Device Name
- Premium Burr Block for drills and 4 sizes of screws FDA UDI
- Model / Reference
- XT 160 FDA UDI
- Description
- Premium Burr Block for drills and 4 sizes of screws FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841685101961 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Dental drill bit extension 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
Dry Heat Sterilization FDA UDI
Category: Dental drill bit extension
A. Titan Instruments by A.Titan Instruments — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental drill bit extension.
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- Restore — Keystone Dental Inc. · Class II
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- Mount Extension — POINTIMPLANT Co., Ltd. · Class I
- Tapered Screw-Vent® — ZIMMER DENTAL INC. · Class I
- AdVent Implant System — ZIMMER DENTAL 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
- A.Titan Instruments
Sources (1)
- FDA UDI c7273f3c-53a1-4d1c-80fb-e09504e9bea2 33 fields · synced Jun 9, 2026