Identity
- Trade Name
- Bicon Impression Component FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- Dental Accessory EUDAMED3.0mm Two-Part Implant Level Impression Kit FDA UDI
- Model / Reference
- 260-100-434 EUDAMEDFDA UDI
- Description
- 3.0mm Two-Part Implant Level Impression Kit FDA UDI
Identifiers
- Catalog Number
- 260-100-434 FDA UDI
- Primary DI / UDI-DI
- 00813110023728 EUDAMEDFDA UDI
- Basic UDI-DI
- 081311002ACC42 EUDAMEDB-00813110023728 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010207 DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY EUDAMEDQ010280 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Dental implant suprastructure, temporary, preformed, single-use
Dental Accessory by Bicon, Llc — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental implant suprastructure, temporary, preformed, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
CE/MDR
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 (3)
- EUDAMED c2806e8a-fa51-4565-abf2-8f3f309a0aa3 61 fields · synced Jul 24, 2026
- EUDAMED 1bb855dd-1f6f-42c6-926c-36abcd6dc776 61 fields · synced May 19, 2026
- FDA UDI 3622da2d-5272-4c5d-bace-2ec10299658f 35 fields · synced May 25, 2026