# K915668: Bisco Cavity Cleanser

- Pathway: 510(k) (Traditional)
- Applicant: Bisco, Inc.
- Decided: Apr 21, 1992 after 125 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 4 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K033938: Clearfil Protect Bond (2004), 4 descendants of its own
- K190271: FiteBac Cavity Cleanser (2020), 2 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
- K962065: 3M Vitrebond Light Cure Glass Ionomer/Base (1996), 1 descendant of its own
- K233768: Papacarie Duo (2024), 0 descendants of its own

Source page: https://510kreport.com/device/K915668
Methodology: https://510kreport.com/methodology