Cavity Varnish
FDA 510(k) K010255 · Rite-Dent Manufacturing Corp.
510(k) numberK010255
Submission
- Device name
- Cavity Varnish
- Applicant
- Rite-Dent Manufacturing Corp.
Hialeah, FL, US - Received
- January 29, 2001
- Decision date
- April 20, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K262243 | Profisil FreeLBH · Traditional | Kettenbach GmbH & Co. KG | 09/03/2026SE |
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| K261404 | UltraEZLBH · Special | Ultradent Products, Inc. | 04/30/2026SE |
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| K241568 | CrystLCare PRO Biorestorative, Fluoride-PlusLBH · Traditional | GreenMark Biomedical, Inc. | 01/02/2025SE |
| K242913 | Jasmate® ToothpasteLBH · Traditional | Jasberry Healthcare Private Limited | 11/22/2024SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K020050 | Enamel Bonding SystemKLE · Traditional | 02/14/2002SE |
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| K011453 | Tooth Shade Resin MaterialEBF · Traditional | 07/23/2001SE |
| K010240 | Polycarboxylate (Pca) CementEMA · Traditional | 03/27/2001SE |
| K003427 | Zinc Phosphate CementEMA · Traditional | 01/24/2001SE |
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Questions and answers
When was Cavity Varnish cleared by the FDA?
Cavity Varnish (K010255) received a 510(k) decision of Substantially Equivalent on April 20, 2001, 81 days after the submission was received.
What is the product code of K010255?
The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.