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Separable Fastener Assembly 10PK - Drill Kit Included, Omnibut
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Separable Fastener Assembly 10PK - Drill Kit Included, Omnibut FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Model / Reference
- SFA10PKDK-OA FDA UDI
Identifiers
- Primary DI / UDI-DI
- D990SFA10PKDKOA0 FDA UDI
- FDA Product Code
- NHA FDA UDIEJX FDA UDINDP FDA UDI
- GMDN Term
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 FDA UDI872.3130 FDA UDI872.3980 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
MR Conditional FDA UDI
Category: Dental implant suprastructure, temporary, preformed, single-useDental prosthesis/implant abutment screwDental prosthesis/implant abutment screw analog, single-use
Separable Fastener Assembly 10PK - Drill Kit Included, Omnibut by Smart Denture Conversions, Llc — Class II — FDA UDI — listed in FDA GUDID
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Smart Denture Conversions, Llc
Sources (1)
- FDA UDI f67f55b9-48ef-4988-9a09-0afe2248a597 33 fields · synced Jun 8, 2026