# K923842: Bisco Universal Bond-3

- Pathway: 510(k) (Traditional)
- Applicant: Bisco, Inc.
- Decided: Sep 29, 1992 after 60 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K101485: All-Etch, All- Etch with Bac; Uni- Etch, Uni- Etch with Bac; Etch- 37, Etch- 37 with Bac; Dark- Etch, Dark Etch (Blue- E (2010), 4 descendants of its own
- K221450: Phosphoric Acid Etching Gel (2022), 0 descendants of its own
- K140846: Eds Combo-Rinse (2014), 0 descendants of its own
- K133078: K-Etchant Syringe; Needle Tip (E) (2013), 0 descendants of its own
- K113401: Ortho-1(Not Finalized) (2012), 0 descendants of its own

Source page: https://510kreport.com/device/K923842
Methodology: https://510kreport.com/methodology