# K150702: Exceed Tx

- Pathway: 510(k) (Traditional)
- Applicant: Great Lakes Orthodontics, Ltd.
- Decided: Mar 24, 2016 after 372 days
- Product code: DYW (Bracket, Plastic, Orthodontic)
- Device class: 2
- Regulation: 21 CFR 872.5470
- 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 K082207 (2009). 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)
- K082207: Orthocad IQ, Cadent, Inc. (2009) Summary page 5.

## Indications for use
eXceed Computerized Precision Bracket Placement Solution is a software system intended for use as an aid in orthodontic treatment planning to correct Malocclusions in Orthodontic Patients. For use by dental professionals trained in orthodontic treatment, including radiographic analyses and treatment planning. eXceed Computerized Precision Bracket Placement Solution is intended for use with commercially available brackets currently used in standard orthodontic treatment, The end product is an indirect bonding tray for use by the Dental professional to place multiple brackets at the same time.

Source page: https://510kreport.com/device/K150702
Methodology: https://510kreport.com/methodology