# K071970: Clear Image Aligner

- Pathway: 510(k) (Traditional)
- Applicant: Specialty Appliance Works, Inc.
- Decided: Sep 25, 2007 after 70 days
- Product code: NXC (Aligner, Sequential)
- 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: 2 generations back to K780619 (1978). 3 ancestors in all.
67 later devices descend from it; 5 cite it directly.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981095: Align System, Align Technology (1998) Summary page 2.
- K040874: Red, White & Blue, Allesee Orthodontic Appliances (2004). Our reading of the summary gave K040879, FDA’s number for Quantex Ferritin (Instrumentation Laboratory CO). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Red, White & Blue”.

## Most influential descendants
- K082556: Clearcorrect (2009), 64 descendants of its own
- K113618: Clearcorrect System (2012), 60 descendants of its own
- K180241: Orthocaps Twinaligner (2018), 15 descendants of its own
- K163689: 3M Clear Tray Aligner (2017), 13 descendants of its own
- K192596: ULab Systems Dental Aligner Kit (2020), 8 descendants of its own

## Indications for use
The Clear ImageTM Aligners system is intended to correct minor discrepancies in the alignment of maloccluded anterior teeth on patients with permanent dentition (second molars) by moving the teeth with a progressive series of clear thin, thermoformed plastic aligners, fabricated in stages to gradually align the teeth over a period of several months. The aligners are completely removable by the patient and may be discontinued at any time.

Source page: https://510kreport.com/device/K071970
Methodology: https://510kreport.com/methodology