Identity
- Trade Name
- Visalys Restorative Primer FDA UDI
- Generic Name
- Dental prosthesis priming agent FDA UDI
- Device Name
- Visalys Restorative Primer FDA UDI
- Model / Reference
- 13581 FDA UDI
- Description
- Visalys Restorative Primer FDA UDI
Identifiers
- Catalog Number
- 13581 FDA UDI
- Primary DI / UDI-DI
- E217135811 FDA UDI
- FDA Product Code
- KLE FDA UDI
- GMDN Term
- Dental prosthesis priming agent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3200 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
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
Category: Dental prosthesis priming agent
Visalys Restorative Primer by Kettenbach GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental prosthesis priming agent.
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- CLEARFIL™ PORCELAIN BOND ACTIVATOR — KURARAY NORITAKE DENTAL INC. · Class II
- CLEARFIL™ CERAMIC PRIMER PLUS — KURARAY NORITAKE DENTAL INC. · Class II
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 c2ba47ca-4513-4be4-9899-e479b5d53c48 34 fields · synced May 31, 2026