Identity
- Trade Name
- Temporary Abutment FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- 3.5 x 4.5mm Temporary Abutment - 2.0mm Post FDA UDI
- Model / Reference
- 260-135-245 FDA UDI
- Description
- 3.5 x 4.5mm Temporary Abutment - 2.0mm Post FDA UDI
Identifiers
- Catalog Number
- 260-135-245 FDA UDI
- Primary DI / UDI-DI
- 00813110020680 FDA UDI
- 510(k) Number
- K853788 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Temporary Abutment by Bicon, Llc — Class II — MDD, MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Cleared under the same submission
K853788 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Bicon, Llc
Sources (2)
- FDA UDI 5ca040e4-2d02-4b71-8fe1-bb77b749f3e4 37 fields · synced Jun 20, 2026
- EUDAMED 1 fields · synced Jun 1, 2026