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Flexi-Snap 12 mm extrafein
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1290UM-50Model 16412Ref 1290UM-100
Identity
- Trade Name
- Flexi-Snap 12 mm extrafein EUDAMEDEDENTA FDA UDI
- Generic Name
- Dental abrasive disk, single-use FDA UDI
- Device Name
- Polierer / Arkansas EUDAMEDFlexi-Snap 12 mm ultra-fine FDA UDI
- Model / Reference
- 16412 EUDAMED1290UM-50 EUDAMEDFDA UDI1290UM-100 EUDAMED
- Description
- Flexi-Snap 12 mm ultra-fine FDA UDI
Identifiers
- Primary DI / UDI-DI
- E3121290UM501 EUDAMEDFDA UDIE3121290UM1001 EUDAMED
- Basic UDI-DI
- ++E31216412DU EUDAMED
- Unit of Use DI
- E3121290UM50101 EUDAMEDE3121290UM100101 EUDAMED
- FDA Product Code
- EJQ FDA UDI
- EMDN Code
- Q010501 DENTAL BURS AND ABRASIVE DISKS, SINGLE-USE EUDAMEDQ01010403 DENTAL ABRASIVE AND POLISHING MATERIALS 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
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
Liquid Chemical FDA UDI
Category: Carbide dental bur, single-use
Flexi-Snap 12 mm extrafein 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 (4)
- EUDAMED 83a4f641-bbdd-421b-826f-ae330251730c 61 fields · synced Jul 13, 2026
- EUDAMED 81ac327b-4f31-4a98-9a94-bbcd114dab4d 61 fields · synced May 18, 2026
- FDA UDI 1ecb0c93-bbcd-40ff-bfa6-6e7c6dfd37fb 33 fields · synced May 30, 2026
- EUDAMED 2b0dd686-d854-45e6-b521-23c5ce0c2278 61 fields · synced Jul 11, 2026