Cavity Cleanser
FDA 510(k) K832497 · Den-Mat Corp.
510(k) numberK832497
Submission
- Device name
- Cavity Cleanser
- Applicant
- Den-Mat Corp.
Mchenry, IL, US - Received
- July 27, 1983
- Decision date
- October 4, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| 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 |
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| K261404 | UltraEZLBH · Special | Ultradent Products, Inc. | 04/30/2026SE |
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| K250714 | FluoroDose VarnishLBH · Traditional | Centrix, Inc. | 11/21/2025SE |
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| 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
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| K983106 | 1ST ImpressionELW · Traditional | 02/09/1999SE |
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| K895269 | Den-Mat Lami-QuickELL · Traditional | 02/22/1990SE |
| K881918 | Light-Cured Zionomer CementEMA · Traditional | 07/15/1988SE |
| K875351 | Den-Mat Poretch (Porcelain Etchant)ELL · Traditional | 03/18/1988SE |
| K872510 | Den-Mat TenureEBF · Traditional | 08/24/1987SE |
| K870130 | Den-Mat Secure Anti-Rotational Post-Core SystemELR · Traditional | 02/19/1987SE |
| K864346 | Rembrandt Porcelain Tinting KitEBF · Traditional | 01/07/1987SE |
| K862449 | Den-Mat Dentin LinkEBF · Traditional | 07/22/1986SE |
| K860971 | Den-Mat Gold Link (Formerly Den-Mat Metal Opaquer)KLE · Traditional | 03/25/1986SE |
Questions and answers
When was Cavity Cleanser cleared by the FDA?
Cavity Cleanser (K832497) received a 510(k) decision of Substantially Equivalent on October 4, 1983, 69 days after the submission was received.
What is the product code of K832497?
The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.