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Dental Accessory
EUDAMEDFDA UDIClass I (EU MDR)
Ref 260-801-085Ref 260-550-600Ref 260-550-605Ref 260-100-861Ref 260-650-615Ref 260-665-600Ref 260-665-605Ref 260-650-610
by Bicon, LLC
Identity
- Trade Name
- UA Healing Cap FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- Dental Accessory EUDAMEDUA6 LP Healing Caps (3) FDA UDI
- Model / Reference
- 260-801-085 EUDAMED260-550-600 EUDAMED260-550-605 EUDAMED260-100-861 EUDAMEDFDA UDI260-650-615 EUDAMED260-665-600 EUDAMED260-665-605 EUDAMED260-650-610 EUDAMED
- Description
- UA6 LP Healing Caps (3) FDA UDI
Identifiers
- Catalog Number
- 260-100-861 FDA UDI
- Primary DI / UDI-DI
- 00813110029812 EUDAMED00813110025302 EUDAMED00813110025319 EUDAMED00813110026958 EUDAMEDFDA UDI00813110025456 EUDAMED00813110025487 EUDAMED00813110025494 EUDAMED00813110025449 EUDAMED
- Basic UDI-DI
- 081311002ACC42 EUDAMEDB-00813110026958 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010280 PROSTHETIC DENTISTRY DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Dental Accessory by Bicon, Llc — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 081311002ACC42 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 081311002ACC42 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bicon, LLC
- EUDAMED SRN
- US-MF-000002782
- Authorised Representative
- Bicon Europe Ltd IE-AR-000002497
Sources (10)
- EUDAMED 7a5c3964-d42e-446d-8e1d-58a627a60baa 61 fields · synced Aug 1, 2026
- EUDAMED 70749750-3947-46e2-8ace-2418e24a1781 61 fields · synced May 17, 2026
- EUDAMED 74d31949-9bae-4c67-9f65-caf0fa5ad21c 61 fields · synced May 17, 2026
- EUDAMED 71139438-54d1-45f9-b053-979447d7b8d3 61 fields · synced May 18, 2026
- EUDAMED 601676fa-21d9-4309-8463-d956af866a43 61 fields · synced May 18, 2026
- EUDAMED c52d36d3-c2d1-4f97-9e15-4843bb472839 61 fields · synced May 19, 2026
- EUDAMED 2ee6d4af-9f82-4e5b-a741-0253c3f77d61 61 fields · synced May 19, 2026
- EUDAMED 16e72500-7517-4235-8ac5-9f2958564794 61 fields · synced May 19, 2026
- EUDAMED 59718081-2f60-43b1-a85e-ac830bb8b4dd 61 fields · synced May 19, 2026
- FDA UDI 9fb9d049-a091-4cbd-9f80-e43edf1dd9d9 35 fields · synced May 30, 2026