Identity
- Trade Name
- Straight Osteotome Kit FDA UDI
- Generic Name
- Dental osteotome set FDA UDI
- Device Name
- Straight Osteotome Kit (4) All 4 with case 1.8mm Straight Osteotome 2.65mm Straight Osteotome 3.4mm Straight Osteotome 4.4mm Straight Osteotome FDA UDI
- Model / Reference
- Straight Osteotome Kit (4) FDA UDI
- Description
- Straight Osteotome Kit (4) All 4 with case 1.8mm Straight Osteotome 2.65mm Straight Osteotome 3.4mm Straight Osteotome 4.4mm Straight Osteotome FDA UDI
Identifiers
- Catalog Number
- OST Kit FDA UDI
- Primary DI / UDI-DI
- D785OSTKIT0 FDA UDI
- FDA Product Code
- DZN FDA UDI
- GMDN Term
- Dental osteotome set FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
Straight Osteotome Kit by Oco Biomedical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 e5f7652a-53da-49af-bab9-d5fd1ca2d667 35 fields · synced Jun 8, 2026