Identity
- Trade Name
- Osteotomy Former FDA UDI
- Generic Name
- Fixture/appliance dental drill bit, reusable FDA UDI
- Device Name
- 3.7mm Osteotomy Former 3.7mm Diameter For placement of the 4mm ISI/TSI/ERI Mandibular Implant FDA UDI
- Model / Reference
- 3.7mm Osteotomy Former FDA UDI
- Description
- 3.7mm Osteotomy Former 3.7mm Diameter For placement of the 4mm ISI/TSI/ERI Mandibular Implant FDA UDI
Identifiers
- Catalog Number
- 0370TN FDA UDI
- Primary DI / UDI-DI
- D7850370T0 FDA UDI
- FDA Product Code
- DZA FDA UDI
- GMDN Term
- Fixture/appliance dental drill bit, 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Fixture/appliance dental drill bit, reusable
Osteotomy Former by Oco Biomedical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Oco Biomedical
Sources (1)
- FDA UDI 2bb8f4a9-8896-4d07-b0f9-30e62259a519 34 fields · synced May 30, 2026