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Flexi-Snap 8 mm extrafein
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1291UM-100Model 16412Ref 1291UM-50
Identity
- Trade Name
- Flexi-Snap 8 mm extrafein EUDAMEDEDENTA FDA UDI
- Generic Name
- Dental abrasive disk, single-use FDA UDI
- Device Name
- Polierer / Arkansas EUDAMEDFlexi-Snap 8 mm ultra-fine FDA UDI
- Model / Reference
- 16412 EUDAMED1291UM-100 EUDAMED1291UM-50 EUDAMEDFDA UDI
- Description
- Flexi-Snap 8 mm ultra-fine FDA UDI
Identifiers
- Primary DI / UDI-DI
- E3121291UM1001 EUDAMEDE3121291UM501 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E31216412DU EUDAMED
- Unit of Use DI
- E3121291UM50101 EUDAMEDE3121291UM100101 EUDAMED
- FDA Product Code
- EJQ FDA UDI
- EMDN Code
- Q01010403 DENTAL ABRASIVE AND POLISHING MATERIALS EUDAMEDQ010501 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
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
Flexi-Snap 8 mm extrafein by Edenta Etablissement — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 2aa407c2-297f-4c4b-964c-72f526049af0 61 fields · synced Sep 30, 2026
- EUDAMED 36fadec4-ac87-4d95-9f5a-dd64b5b39180 61 fields · synced May 19, 2026
- FDA UDI f7559364-fd28-43f4-8b18-8de8c1cfb3f3 33 fields · synced May 30, 2026
- EUDAMED 5c3bb013-7499-4778-aba7-561afdda1a89 61 fields · synced Jul 13, 2026