# K071688: Reliance S.E.P.

- Pathway: 510(k) (Traditional)
- Applicant: Reliance Orthodontic Products, Inc.
- Decided: Sep 7, 2007 after 79 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: 4 generations back to K900510 (1990). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984246: Prompt L-Pop, Espe Dental AG (1999) Summary page 1.

## Indications for use
The Reliance S.E.P. is a one step self etching primer intended to be used for the preparation of a tooth surface prior to bonding an orthodontic appliance(s) with a light cure adhesive.

Source page: https://510kreport.com/device/K071688
Methodology: https://510kreport.com/methodology