Identity
- Trade Name
- Temporary Cylinder 1PK, Omnibut FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Model / Reference
- TC1PK-OA FDA UDI
Identifiers
- Primary DI / UDI-DI
- D990TC1PKOA0 FDA UDI
- FDA Product Code
- EJX FDA UDI
- GMDN Term
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3130 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
Yes
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-use
Temporary Cylinder 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 0987f97e-5119-4c61-9651-9a148ce41c16 33 fields · synced May 31, 2026