Paint- on Polish Agent
FDA 510(k) K070306 · Dentsply International, Inc.
510(k) numberK070306
Submission
- Device name
- Paint- on Polish Agent
- Applicant
- Dentsply International, Inc.
York, PA, US - Received
- February 1, 2007
- Decision date
- March 22, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code EBD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254091 | Glossy Coat (15ML)EBD · Traditional | YAMAHACHI DENTAL MFG., Co. | 04/06/2026SE |
| K250804 | Id Light Cure SystemEBD · Traditional | Id Korea Co., Ltd. | 06/04/2025SE |
| K240735 | visio.lign color, visio.lign shieldEBD · Traditional | Bredent GmbH & Co. KG | 12/12/2024SE |
| K223365 | RODIN Palette Naturalizing KitEBD · Traditional | Belport Company, Inc., Gingi-Pak | 03/27/2023SE |
| K211854 | VITA Akzent LCEBD · Traditional | Vita Zahnfabrik GmbH H Rauter & CO | 11/22/2021SE |
| K162408 | Nano Varnish, Plaquit, Lightpaint on SurfaceEBD · Traditional | Dreve Dentamid GmbH | 04/05/2018SE |
| K163568 | Shofu Resin GlazeEBD · Traditional | Shofu Dental Corporation | 08/16/2017SE |
| K133836 | Optiglaze ColorEBD · Traditional | GC America, Inc. | 03/06/2014SE |
| K123761 | Vita Enamic StainsEBD · Traditional | Innovation Meditech GmbH | 03/01/2013SE |
| K093019 | Enamelite Acryseal Spray SealantEBD · Traditional | Enamelite, LLC | 12/22/2009SE |
More from Enamelite, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K160207 | ATLANTIS ISUS Implant SuprastructuresNHA · Traditional | 09/21/2016SE |
| K160232 | Disposable Barrier Sleeves and CoversPEM · Traditional | 06/07/2016SE |
| K151439 | Atlantis IsusNHA · Traditional | 02/19/2016SE |
| K152247 | ATLANTIS CrownEIH · Traditional | 01/29/2016SE |
| K151039 | ATLANTIS Abutment for NobelActive 3.0NHA · Traditional | 01/14/2016SE |
| K151619 | Prime&Bond Elect Universal Dental AdhesiveKLE · Traditional | 10/30/2015SE |
| K150535 | Cavitron Touch Ultrasonic Scaling SystemELC · Traditional | 06/16/2015SE |
| K142178 | Proroot Mta White, Proroot Mta GrayKIF · Traditional | 02/26/2015SE |
| K131907 | Raypex 6LQY · Traditional | 01/31/2014SE |
| K131644 | Ankylos Syncone Abutment 5(DEGREE)NHA · Traditional | 01/22/2014SE |
Questions and answers
When was Paint- on Polish Agent cleared by the FDA?
Paint- on Polish Agent (K070306) received a 510(k) decision of Substantially Equivalent on March 22, 2007, 49 days after the submission was received.
What is the product code of K070306?
The FDA product code is EBD – Coating, Filling Material, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3310.