# K210945: Ultra SEP

- Pathway: 510(k) (Traditional)
- Applicant: Reliance Orthodontic Products, Inc.
- Decided: Jul 8, 2021 after 100 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 4.

## Indications for use
Ultra SEP is a self etching primer intended to be used for the preparation of an enamel surface prior to bonding with a light cure orthodontic adhesive.

Source page: https://510kreport.com/device/K210945
Methodology: https://510kreport.com/methodology