Seal & Protect Protective Sealant for Exposed Dentine
FDA 510(k) K992822 · Dentsply Intl.
510(k) numberK992822
Submission
- Device name
- Seal & Protect Protective Sealant for Exposed Dentine
- Applicant
- Dentsply Intl.
York, PA, US - Received
- August 23, 1999
- Decision date
- November 17, 1999
- 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 |
|---|---|---|
| K140347 | Ankylos C/X Implant SystemDZE · Traditional | 08/20/2014SE |
| K130862 | Cavitron Prophy-Jet Air Polishing Prophylaxis SystemELC · Traditional | 07/23/2013SE |
| K123615 | Iris - High Strength Glass CeramicEIH · Traditional | 02/22/2013SE |
| K103244 | Qmix 2IN1 Endodontic Irrigating SolutionKJJ · Traditional | 02/14/2011SE |
| K093221 | Pre-Cemented Orthodontic Bracket System Extension IIDYH · Special | 10/30/2009SE |
| K083805 | Ankylos C/X Dental Implant SystemDZE · Traditional | 05/22/2009SE |
| K082198 | Durashield PlusLBH · Traditional | 10/29/2008SE |
| K072730 | Friadent Cercon and Ankylos Cercon Balance AbutmentsNHA · Traditional | 03/27/2008SE |
| K072989 | Axis SystemEFB · Traditional | 01/28/2008SE |
| K073117 | Dentin Desensitizer AgentLBH · Traditional | 12/19/2007SE |
Questions and answers
When was Seal & Protect Protective Sealant for Exposed Dentine cleared by the FDA?
Seal & Protect Protective Sealant for Exposed Dentine (K992822) received a 510(k) decision of Substantially Equivalent on November 17, 1999, 86 days after the submission was received.
What is the product code of K992822?
The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.