Identity
- Trade Name
- TREPHINE DRILL FDA UDI
- Generic Name
- Bone trephine, reusable FDA UDI
- Device Name
- Surgical Trephine Drill 3mm FDA UDI
- Model / Reference
- DDR-TR03 FDA UDI
- Description
- Surgical Trephine Drill 3mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290113355941 FDA UDI
- FDA Product Code
- DZA FDA UDI
- GMDN Term
- Bone trephine, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4130 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
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: Bone trephine, reusable
Trephine Drill by Dentin Implants Technologies Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- ZOLL-DENTAL — Zoll-Dental · Class I
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- Borchardt Flat Trephine 5 mm Borchardt Shaft Ø 1.8 mm Stainless Steel — SURTEX INSTRUMENTS LTD · Class I
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
- Dentin Implants Technologies Ltd
Sources (1)
- FDA UDI 5ba13454-93b7-4369-9ba2-4cdfc7475cf7 33 fields · synced May 30, 2026