Dental Varnish
FDA 510(k) K760982 · Adp Intl., Inc.
510(k) numberK760982
Submission
- Device name
- Dental Varnish
- Applicant
- Adp Intl., Inc.
Mchenry, IL, US - Received
- October 21, 1976
- Decision date
- November 15, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K760988 | Dental Handpieces · Traditional | 11/15/1976SE |
| K760987 | Diamond StonesDZP · Traditional | 11/15/1976SE |
| K760986 | Carbide Dental BursEJL · Traditional | 11/15/1976SE |
| K760985 | Hand InstrumentsEKW · Traditional | 11/15/1976SE |
| K760984 | Orthodontic InstrumentsJEX · Traditional | 11/15/1976SE |
| K760983 | Endodontic InstrumentsEKN · Traditional | 11/15/1976SE |
| K760981 | Alginate Impression MaterialELW · Traditional | 11/15/1976SE |
| K760980 | Dental AlloyEJJ · Traditional | 11/15/1976SE |
| K760979 | Composite MaterialEBF · Traditional | 11/15/1976SE |
| K760978 | Zinc CementEMA · Traditional | 11/15/1976SE |
Questions and answers
When was Dental Varnish cleared by the FDA?
Dental Varnish (K760982) received a 510(k) decision of Substantially Equivalent on November 15, 1976, 25 days after the submission was received.
What is the product code of K760982?
The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.