Identity
- Trade Name
- Flexi- Snap - Trial Kit EUDAMEDEDENTA FDA UDI
- Generic Name
- Dental abrasive disk, single-use FDA UDI
- Device Name
- Polierer / Arkansas EUDAMEDFlexi- Snap - Trial Kit FDA UDI
- Model / Reference
- 16412 EUDAMEDFSTK EUDAMEDFDA UDI
- Description
- Flexi- Snap - Trial Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- E312FSTK1 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E31216412DU EUDAMED
- FDA Product Code
- EJQ FDA UDI
- EMDN Code
- Q010501 DENTAL BURS AND ABRASIVE DISKS, SINGLE-USE EUDAMED
- GMDN Term
- Dental abrasive disk, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.6010 FDA UDI
- Market of Registration
- Liechtenstein 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Liquid Chemical FDA UDI
Category: Carbide dental bur, single-use
Flexi- Snap - Trial Kit by Edenta Etablissement — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++E31216412DU | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Edenta Etablissement
- EUDAMED SRN
- LI-MF-000011937
Sources (2)
- EUDAMED 54ea4c01-4caf-49e1-b7a1-63f7fd78b02a 61 fields · synced Jun 17, 2026
- FDA UDI ebce516c-650f-43dd-a3d0-58a00930457b 33 fields · synced May 30, 2026