# K113197: Apc Flash-Free Adhesive

- Pathway: 510(k) (Traditional)
- Applicant: 3M Unitek Corporation
- Decided: Feb 2, 2012 after 94 days
- Product code: DYH (Adhesive, Bracket And Tooth Conditioner, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3750
- 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 K911271 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911271: Adhesive Precoated Brackets, Unitek Corp. (1991) Summary page 1.
- K020394: Apc Plus Adhesive, 3M Unitek (2002) Summary page 1.

## Indications for use
APC™ Flash-Free Adhesive is indicated for use in bonding orthodontic appliances for orthodontic treatment.

Source page: https://510kreport.com/device/K113197
Methodology: https://510kreport.com/methodology