Identity
- Trade Name
- Pre-Coated TiBase 1PK, Omnibut FDA UDI
- Generic Name
- Dental prosthesis/implant abutment screw analog, single-use FDA UDI
- Model / Reference
- PTB1PK-OA FDA UDI
Identifiers
- Primary DI / UDI-DI
- D990PTB1PKOA0 FDA UDI
- FDA Product Code
- NDP FDA UDIEJX FDA UDI
- GMDN Term
- Dental prosthesis/implant abutment screw analog, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 FDA UDI872.3130 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
FDA UDI
MR Conditional FDA UDI
Category: Dental implant suprastructure, temporary, preformed, single-useDental prosthesis/implant abutment screw analog, single-use
Pre-Coated TiBase 1PK, Omnibut by Smart Denture Conversions, Llc — 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
- Smart Denture Conversions, Llc
Sources (1)
- FDA UDI 334e576e-380c-47ba-9c48-b3d15ae7b39b 33 fields · synced May 30, 2026