Sensodyne Sealant Dentin Conditioning System
FDA 510(k) K884533 · Block Drug Company, Inc.
510(k) numberK884533
Submission
- Device name
- Sensodyne Sealant Dentin Conditioning System
- Applicant
- Block Drug Company, Inc.
Jersey City, NJ, US - Received
- October 28, 1988
- Decision date
- April 12, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K260485 | Any-EtchKLE · Traditional | Mediclus Co., Ltd. | 05/14/2026SE |
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| K251587 | VITA VMLC PrimerKLE · Traditional | Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | 02/23/2026SE |
| K252151 | els unibondKLE · Traditional | Saremco Dental AG | 12/05/2025SE |
| K252469 | Magnabond Se; Magnabond Universal; Magnabond Universal DcaKLE · Traditional | Dmp Dental Industry S.A. | 11/06/2025SE |
| K251124 | G-Bond UniversalKLE · Traditional | GC America, Inc. | 10/02/2025SE |
| K242530 | HF-Etchant Hydrofluoric Acid Etching GelKLE · Traditional | Rizhao Huge Biomaterials Company, Ltd. | 12/20/2024SE |
| K242749 | TopCEM Ceramic Primer Ceramic Coupling AgentKLE · Traditional | Rizhao Huge Biomaterials Company, Ltd. | 11/08/2024SE |
More from Rizhao Huge Biomaterials Company, Ltd.
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| K945462 | Super Poli-Grip Denture Adhesive CreamKOT · Traditional | 12/20/1994SE |
| K935925 | Vision Prophy Paste with FluorideEJR · Traditional | 01/26/1994SE |
| K933893 | Vision Prophy Paste Without FluorideEJR · Traditional | 11/16/1993SE |
| K881974 | Proficient(Tm) Prophylaxis AngleEFB · Traditional | 07/25/1988SE |
| K872225 | Super Poli-Grip & Wernet's Denture Adhes. PowderKOT · Traditional | 06/30/1987SE |
| K862876 | New Super Poli-Grip Denture Adhesive CreamKOO · Traditional | 08/29/1986SE |
| K800831 | Py-Co-Prox TM Dental BrushEFW · Traditional | 05/08/1980SE |
| K791064 | Duo Two Layer Denture CleanserEFT · Traditional | 10/09/1979SE |
| K780849 | Dentrol Liquid Denture Adhesive · Traditional | 07/31/1978SE |
Questions and answers
When was Sensodyne Sealant Dentin Conditioning System cleared by the FDA?
Sensodyne Sealant Dentin Conditioning System (K884533) received a 510(k) decision of Substantially Equivalent on April 12, 1989, 166 days after the submission was received.
What is the product code of K884533?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.