Identity
- Trade Name
- Stealth EUDAMEDStealth Abutment FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Dental Abutment EUDAMED5.0 x 4.0mm 0° Stealth Abutment - 2.5mm Post FDA UDI
- Model / Reference
- 260-250-321 EUDAMEDFDA UDI
- Description
- 5.0 x 4.0mm 0° Stealth Abutment - 2.5mm Post FDA UDI
Identifiers
- Catalog Number
- 260-250-321 FDA UDI
- Primary DI / UDI-DI
- 00813110021809 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00813110021809 EUDAMED081311002TAbut5L EUDAMED
- 510(k) Number
- K092035 FDA UDI
- FDA Product Code
- NHA FDA UDI
- EMDN Code
- P010299 ODONTOLOGICAL PROSTHESES - OTHER EUDAMED
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
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
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Dental implant suprastructure, permanent, preformed
Stealth by Bicon, Llc — Class IIb — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, permanent, preformed.
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- GS System — OSSTEM IMPLANT Co., Ltd. · Class II
- Temporary Abutment — Cybermed Inc. · Class II
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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 | B-00813110021809 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | B-00813110021809 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | 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 b196aa40-d844-4ee5-9146-350e2fa1f778 61 fields · synced Jul 20, 2026
- EUDAMED 9d8677fb-f294-4fb5-aa5c-2609f1c9a630 61 fields · synced May 17, 2026
- FDA UDI 0721c7ec-0c6e-4123-a165-b1209b644fc9 36 fields · synced May 30, 2026