# K181910: BracePaste MTP Light Cure Primer

- Pathway: 510(k) (Traditional)
- Applicant: American Orthodontics
- Decided: Oct 15, 2018 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: 2 generations back to K942493 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962785: 3M Dent System, 3M Company (1996) Summary page 4.

## Indications for use
Orthodontic Primers are intended to be used in the bonding procedure (direct or indirect) of brackets and tubes by preparing the enamel during orthodontic treatment to increase adhesion to wet or dry, normal and atypical enamel surfaces. The Primer wets the bonding surface of the object to be bonded (i.e. enamel, composite materials, etc.) to promote adhesion.

Source page: https://510kreport.com/device/K181910
Methodology: https://510kreport.com/methodology