Identity
- Trade Name
- Tray FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- Dental Accessory EUDAMED2.0mm Pilot Drill Tray FDA UDI
- Model / Reference
- 260-104-999 EUDAMEDFDA UDI
- Description
- 2.0mm Pilot Drill Tray FDA UDI
Identifiers
- Catalog Number
- 260-104-999 FDA UDI
- Primary DI / UDI-DI
- 00813110029102 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00813110029102 EUDAMED081311002ACC42 EUDAMED
- FDA Product Code
- FSM FDA UDI
- EMDN Code
- S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMEDQ010280 PROSTHETIC DENTISTRY DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 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
Category: Instrument tray, reusable
Dental Accessory by Bicon, Llc — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Instrument tray, reusable.
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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 | B-00813110029102 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-00813110029102 | 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 1e21bd24-e9fe-4d66-ab23-8a25a12d07d6 61 fields · synced Jul 25, 2026
- EUDAMED e241409d-e756-48cc-8166-780ff0dc3816 61 fields · synced May 19, 2026
- FDA UDI b5be4547-478c-4bd0-b24b-68206f505ed5 35 fields · synced May 30, 2026