Identity
- Trade Name
- edelweiss VENEER KIT FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Toolbox with content 20 Veneers (1x Veneer Set 13-23 S up, 1x Veneer Set 14-24 M up, 1x Veneer Set 13-23 L up), 20x Composite tips (each 5 pcs of A0, A1, A2 and Enamel), 1x Veneer Bond bottle + Accessoires FDA UDI
- Model / Reference
- 17100 FDA UDI
- Description
- Toolbox with content 20 Veneers (1x Veneer Set 13-23 S up, 1x Veneer Set 14-24 M up, 1x Veneer Set 13-23 L up), 20x Composite tips (each 5 pcs of A0, A1, A2 and Enamel), 1x Veneer Bond bottle + Accessoires FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09120046322681 FDA UDI
- FDA Product Code
- EBF FDA UDI
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3690 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental composite resinDental veneer, professional
edelweiss VENEER KIT by edelweiss dentistry products gmbh — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- COMPONEER — Coltène/Whaledent AG · Class II
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- Ceramill — Vertex-Dental B.V. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- edelweiss dentistry products gmbh
Sources (1)
- FDA UDI 0352a426-3d8f-41c4-bca2-ea84137aaad3 33 fields · synced Jun 8, 2026