Paint- on Polish Agent
by Dentsply International Inc.
510(k) K070306
Paint- on Polish Agent is a Class II device made by Dentsply International Inc., cleared under FDA 510(k) K070306 on 22 Mar 2007, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK070306 | Date22 Mar 2007 | StatusActive |
Official records
- FDA 510(k) database K070306
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EBD
- FDA applicant
- Dentsply International, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3310
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code EBD (Coating, Filling Material, Resin).
- BISCOVER LIQUID POLISH KIT, BISCOVER LIQUID POLISH AND BISCOVER VISCOSITY MODIFIER by BISCO INC.
- BISCOVER LED by BISCO INC.
- GLOSSY COAT (15ML) by YAMAHACHI DENTAL MFG., CO.
- SHOFU RESIN GLAZE by SHOFU DENTAL CORP.
- COLORANT by Vivadent (Usa), Inc.
- ENAMELITE ACRYSEAL SPRAY SEALANT by Enamelite, LLC
- BELLEGLAZE by Kerr Dental Materials Center
- J & J LIGHT CURING DENTIN/ENAMEL BONDING AGENT by Johnson & Johnson Professionals, Inc.
- Renamel® Flowable Microhybrid 7011A3 by Cosmedent, Inc.
- ANTERIOR/POSTERIOR RESTORATIVE, BOND by SCIENTIFIC PHARMACEUTICALS, INC.