# K082207: Orthocad IQ

- Pathway: 510(k) (Traditional)
- Applicant: Cadent, Inc.
- Decided: Oct 23, 2009 after 444 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
No predicates in its family tree.
44 later devices descend from it; 4 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Cadent Inc.'s OrthoCAD System: named in the summary without a submission number
- (no number) Align Technologies, Inc.'s Invisalign System: named in the summary without a submission number
- (no number) OraMetrix, Inc.'s SureSmile System: named in the summary without a submission number

## Most influential descendants
- K152086: 3Shape Ortho System (2016), 33 descendants of its own
- K171634: Ortho System (2018), 14 descendants of its own
- K171295: ULab Systems Treatment Planning Software (2018), 13 descendants of its own
- K180941: Ortho System (2018), 8 descendants of its own
- K171122: CEREC Ortho Software (2018), 5 descendants of its own

## Indications for use
OrthoCAD iQ is a computer-guided system intended for use as an aid in orthodontic treatment planning for use by dental professionals trained in orthodontic treatment including radiographic analyses and treatment planning. OrthoCAD iQ is intended for use with commercially-available brackets and wires that apply continuous gentle force to reposition the teeth. It also uses indirect bonding trays to affix the brackets in position.

Source page: https://510kreport.com/device/K082207
Methodology: https://510kreport.com/methodology