Fluorilaq
FDA 510(k) K030488 · Pascal Co., Inc.
510(k) numberK030488
Submission
- Device name
- Fluorilaq
- Applicant
- Pascal Co., Inc.
Bellevue, WA, US - Received
- February 14, 2003
- Decision date
- May 2, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K262243 | Profisil FreeLBH · Traditional | Kettenbach GmbH & Co. KG | 09/03/2026SE |
| K253052 | Fluoride Varnish (Type A,Type C)LBH · Traditional | Nagy Oral Technology Qinhuangdao Co., Ltd. | 06/11/2026SE |
| K252073 | VOCO Profluorid Varnish + BioMinLBH · Traditional | Voco GmbH | 05/01/2026SE |
| K261404 | UltraEZLBH · Special | Ultradent Products, Inc. | 04/30/2026SE |
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| K250714 | FluoroDose VarnishLBH · Traditional | Centrix, Inc. | 11/21/2025SE |
| K243777 | Rennou Varnish (3% / Spearmint); Rennou Varnish (3% / Strawberry); Rennou Varnish (3%…LBH · Traditional | Theodent, LLC | 05/27/2025SE |
| K241489 | ReminGelLBH · Traditional | Inter-Med, Inc. | 01/08/2025SE |
| K241568 | CrystLCare PRO Biorestorative, Fluoride-PlusLBH · Traditional | GreenMark Biomedical, Inc. | 01/02/2025SE |
| K242913 | Jasmate® ToothpasteLBH · Traditional | Jasberry Healthcare Private Limited | 11/22/2024SE |
More from Jasberry Healthcare Private Limited
| 510(k) | Device | Decision |
|---|---|---|
| K102526 | BLO2X Oxygen BlockerEBF · Traditional | 10/22/2010SE |
| K090597 | Fluorilaq Sodium Fluoride Cavity VarnishLBH · Special | 03/16/2009SE |
| K040988 | Zircon-F Prophylaxis PasteEJR · Traditional | 07/07/2004SE |
| K040661 | Radent Prophy PasteEJR · Traditional | 06/09/2004SE |
| K012889 | Banicide Liquid Chemical Sterilant/High-Level DisinfectantMED · Traditional | 05/27/2003SE |
| K912632 | OccludeEFH · Traditional | 01/17/1992SE |
| K911259 | HydentEFH · Traditional | 06/06/1991SE |
Questions and answers
When was Fluorilaq cleared by the FDA?
Fluorilaq (K030488) received a 510(k) decision of Substantially Equivalent on May 2, 2003, 77 days after the submission was received.
What is the product code of K030488?
The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.