Contac, a Dentin Sealant
FDA 510(k) K881026 · Harry J. Bosworth Co.
510(k) numberK881026
Submission
- Device name
- Contac, a Dentin Sealant
- Applicant
- Harry J. Bosworth Co.
Skokie, IL, US - Received
- March 10, 1988
- Decision date
- June 1, 1988
- 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 |
|---|---|---|
| K103585 | Bosworth Aegis Liner & Restorative Material W/AcpEMA · Traditional | 03/04/2011SE |
| K100731 | Bosworth Air PolisherEFB · Traditional | 12/03/2010SE |
| K061611 | Bosworth Dentin ResinKLE · Traditional | 09/11/2006SE |
| K051224 | Bosworth SealEBC · Traditional | 07/28/2005SE |
| K043170 | Bosworth BondKLE · Traditional | 02/25/2005SE |
| K040548 | Aegis Ortho Light-Cured Orthodontic AdhesiveDYH · Traditional | 03/19/2004SE |
| K040547 | Aegis Ortho Dual-Cured Orthodontic AdhesiveDYH · Traditional | 03/19/2004SE |
| K033751 | Aegis Pit & Fissure Sealant with AcpEBC · Traditional | 02/05/2004SE |
| K031439 | Alginate Impression Material III (Fast & Regular)ELW · Traditional | 10/02/2003SE |
| K031811 | Pit & Fissure Sealant with FluorideEBC · Traditional | 09/04/2003SE |
Questions and answers
When was Contac, a Dentin Sealant cleared by the FDA?
Contac, a Dentin Sealant (K881026) received a 510(k) decision of Substantially Equivalent on June 1, 1988, 83 days after the submission was received.
What is the product code of K881026?
The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.