# K832497: Cavity Cleanser

- Pathway: 510(k) (Traditional)
- Applicant: Den-Mat Corp.
- Decided: Oct 4, 1983 after 69 days
- Product code: LBH (Varnish, Cavity)
- Device class: 2
- Regulation: 21 CFR 872.3260
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K033938: Clearfil Protect Bond (2004), 4 descendants of its own
- K150704: PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit (Universal (A2)), Introductory Kit (Clear), Sample Pack (Universal (A2)), Paste (Universal (A2)), Paste (Clear), Paste (Brown (A4)), Paste (White), Paste (Opaque), Try-in Paste (Universal (A2)), Try-in Paste (Clear), Try-in Paste (Brown (A4)), Try-in Paste (White), Try-in Paste (Opaque), Tooth Primer (2015), 2 descendants of its own
- K210504: PANAVIA Veneer LC (2021), 0 descendants of its own
- K191524: Visalys Tooth Primer (2019), 0 descendants of its own
- K183391: Novidia Universal Bond (2019), 0 descendants of its own

Source page: https://510kreport.com/device/K832497
Methodology: https://510kreport.com/methodology