# 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

- Pathway: 510(k) (Traditional)
- Applicant: Bisco, Inc.
- Decided: Aug 26, 2010 after 90 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
Longest line of descent: 1 generation back to K923842 (1992). 1 ancestor in all.
4 later devices descend from it; 4 cite 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)
- K923842: Bisco Universal Bond-3, Bisco, Inc. (1992) Summary page 1.

## Cited in the summary but kept off the family tree
- K094560: Ecliptomer. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- 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

## Indications for use
Bisco Etchants consist of semi-gel phosphoric acids. The principle uses of the Bisco Etchants are: 1. Etching and cleaning of dentin and enamel 2. Cleaning of restorative surfaces prior to bonding

Source page: https://510kreport.com/device/K101485
Methodology: https://510kreport.com/methodology