Identity
- Trade Name
- Visalys Veneer FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Visalys Veneer Size S, Lower/UK 33-43/US22-US27 FDA UDI
- Model / Reference
- 28433-43S FDA UDI
- Description
- Visalys Veneer Size S, Lower/UK 33-43/US22-US27 FDA UDI
Identifiers
- Catalog Number
- 28433-43S FDA UDI
- Primary DI / UDI-DI
- E2172843343S1 FDA UDI
- 510(k) Number
- K982692 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
- Not 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Visalys Veneer by Kettenbach GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Kettenbach GmbH & Co. KG
Sources (1)
- FDA UDI 5b04bc43-d6d9-4aae-9b0e-f8cafc9b8c1d 36 fields · synced Jun 7, 2026