Identity
- Trade Name
- QuickLine Varnish Base and Catalyst (10ml each) FDA UDI
- Generic Name
- Dental prosthesis priming agent FDA UDI
- Device Name
- An acrylate-based light cured liquid material that when applied to polymerized composite surfaces, custom trays or temporary crown and bridges and light cured, produces a hard, gloss surface which is solvent and resistant. It also may be used as an oxygen barrier to pre-polymerized acrylic materials that after polymenization which will prevent a remaining oxygen inhibited layer. An additional use is to act as an acrylic condition when applied to acrylic upon receiving subsequent layer of acrylic to aid in adhesion of all acrylic materials involved. FDA UDI
- Model / Reference
- 220182 FDA UDI
- Description
- An acrylate-based light cured liquid material that when applied to polymerized composite surfaces, custom trays or temporary crown and bridges and light cured, produces a hard, gloss surface which is solvent and resistant. It also may be used as an oxygen barrier to pre-polymerized acrylic materials that after polymenization which will prevent a remaining oxygen inhibited layer. An additional use is to act as an acrylic condition when applied to acrylic upon receiving subsequent layer of acrylic to aid in adhesion of all acrylic materials involved. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841549115974 FDA UDI
- 510(k) Number
- K992609 FDA UDI
- FDA Product Code
- EBI FDA UDI
- GMDN Term
- Dental prosthesis priming agent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3760 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
QuickLine Varnish Base and Catalyst (10ml each) by Sterngold Dental LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental prosthesis priming agent.
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- CLEARFIL™ CERAMIC PRIMER PLUS — KURARAY NORITAKE DENTAL INC. · Class II
Cleared under the same submission
K992609 also covers:
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
- Sterngold Dental LLC
Sources (1)
- FDA UDI b0e5a526-30c4-4a1a-bee9-2bdca7c54436 35 fields · synced Jun 8, 2026