# K093014: American Dental Products SE Bondeasy

- Pathway: 510(k) (Traditional)
- Applicant: American Dental Products, Inc.
- Decided: Apr 16, 2010 after 199 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 K011159 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011159: One-Step Plus, Bisco, Inc. (2001) Summary page 1.

## Indications for use
As a Universal Self-Etching Adhcsive Bonding System, BONDEASIER SE SYSTEM is indicated to be uscd as an universal dental adhesive to etch, prime and bond to a tooth structure and meth(acrylic) dental composite.

Source page: https://510kreport.com/device/K093014
Methodology: https://510kreport.com/methodology