Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800)
FDA 510(k) K230333 · Kettenbach GmbH & Co. KG
510(k) numberK230333
Submission
- Device name
- Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800)
- Applicant
- Kettenbach GmbH & Co. KG
Eschenburg, DE - Received
- February 7, 2023
- Decision date
- July 24, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code LBH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K260830 | APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)LBH · Traditional | Sangi Co., Ltd. | 03/18/2026SE |
| 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 |
|---|---|---|
| K262243 | Profisil FreeLBH · Traditional | 09/03/2026SE |
| K250267 | Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (15062)…EBF · Traditional | 03/14/2025SE |
| K191527 | Visalys CemCore, Visalys Cem Core Try In PasteEMA · Traditional | 11/08/2019SE |
| K191523 | Visalys Restorative PrimerKLE · Traditional | 10/09/2019SE |
| K191524 | Visalys Tooth PrimerKLE · Traditional | 09/29/2019SE |
| K143104 | Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-XEBF · Traditional | 03/25/2015SE |
| K122039 | Kingscross PL-C+B-10, Kingscross PL-C+B-12, Kingscross PL-C+B-08, Kingscross BEBG · Traditional | 12/27/2012SE |
| K113279 | Identium Heavy, Identium Medium, Identium Scan Heavy, Identium Scan Medium, Identium…ELW · Special | 11/14/2011SE |
| K092867 | Identium Heavy, Medium, Medium Soft, LightELW · Traditional | 10/01/2009SE |
| K083701 | Panasil Initial Contact and Panasil TrayELW · Special | 01/09/2009SE |
Questions and answers
When was Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800) cleared by the FDA?
Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800) (K230333) received a 510(k) decision of Substantially Equivalent on July 24, 2023, 167 days after the submission was received.
What is the product code of K230333?
The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.