Identity
- Trade Name
- Silane FDA UDI
- Generic Name
- Dental prosthesis priming agent FDA UDI
- Device Name
- Viscous 9.5% Hydrofluoric Acid Solution. For porcelain veneers and inlays prior to cementation or repairs. Silane refill includes (4) 1.2mL prefilled silane syringes. FDA UDI
- Model / Reference
- 502505 FDA UDI
- Description
- Viscous 9.5% Hydrofluoric Acid Solution. For porcelain veneers and inlays prior to cementation or repairs. Silane refill includes (4) 1.2mL prefilled silane syringes. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10818207020199 FDA UDI
- 510(k) Number
- K933766 FDA UDI
- FDA Product Code
- EBF FDA UDI
- GMDN Term
- Dental prosthesis priming agent 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
No
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
Yes
FDA UDI
Category: Dental prosthesis priming agent
Silane by Vista Dental — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental prosthesis priming agent.
- ACRIFIX — DeltaMed GmbH · Class II
- HC PRIMER — SHOFU DENTAL CORP. · Class II
- CLEARFIL™ CERAMIC PRIMER PLUS — KURARAY NORITAKE DENTAL INC. · Class II
- Mirage Silane Bond Enhancer — Chameleon Dental Products, Inc.
- 3Delta Denture Bond — DeltaMed GmbH · Class II
- CLEARFIL™ PORCELAIN BOND ACTIVATOR — KURARAY NORITAKE DENTAL INC. · Class II
- CLEARFIL™ CERAMIC PRIMER PLUS — KURARAY NORITAKE DENTAL INC. · Class II
- Porcelain Primer — BISCO INC. · Class II
Cleared under the same submission
K933766 also covers:
- Multi Bond — B.J.M. LABORATORIES LTD
- Multi Bond — B.J.M. LABORATORIES LTD
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC
- Integra Bond — PREMIER DENTAL PRODUCTS COMPANY
- Integra Bond — PREMIER DENTAL PRODUCTS COMPANY
- Integra Bond — PREMIER DENTAL PRODUCTS COMPANY
- Integra Bond — PREMIER DENTAL PRODUCTS COMPANY
- Premier — PREMIER DENTAL PRODUCTS COMPANY
- Porcelain Etch — Vista Dental
- Porcelain Etch — Vista Dental
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Vista Dental
Sources (1)
- FDA UDI 3a9bb8e3-a5a7-4344-96a3-0169221f90ed 34 fields · synced Jun 1, 2026