Identity
- Trade Name
- Guided Surgery FDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Device Name
- Dental Accessory EUDAMED4.0mm Guided Surgery Rings FDA UDI
- Model / Reference
- 260-940-005 EUDAMEDFDA UDI
- Description
- 4.0mm Guided Surgery Rings FDA UDI
Identifiers
- Catalog Number
- 260-940-005 FDA UDI
- Primary DI / UDI-DI
- 00813110026309 EUDAMEDFDA UDI
- Basic UDI-DI
- 081311002ACC42 EUDAMEDB-00813110026309 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010280 PROSTHETIC DENTISTRY DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Surgical drill guide, reusable 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
No
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
Moist Heat or Steam Sterilization FDA UDI
Dental Accessory by Bicon, Llc — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081311002ACC42 | Class I | Active |
| EUDAMED | European Union | CE/MDD | 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 420da1a3-e2c1-4b8b-b923-bed8a5240b0f 61 fields · synced Jun 17, 2026
- EUDAMED 483f92ee-047f-4399-ba28-ba0ec13fbb8d 61 fields · synced May 16, 2026
- FDA UDI 2059b2d2-f051-4132-ab2b-072b3faeddd6 35 fields · synced May 30, 2026