# K981095: Align System

- Pathway: 510(k) (Traditional)
- Applicant: Align Technology
- Decided: Sep 8, 1998 after 166 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: 1 generation back to K780619 (1978). 1 ancestor in all.
135 later devices descend from it; 9 cite it directly.
0 of 137 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K780619: Preformed Tooth Positioner, Tp Laboratories, Inc. (1978) Summary page 4.
- (no number) Great Lakes Orthodontics Preformed Tooth Positioner: named in the summary without a submission number
- (no number) Ortho-Tain Tooth Positioner: named in the summary without a submission number

## Most influential descendants
- K081960: Invisalign System (2008), 82 descendants of its own
- K071970: Clear Image Aligner (2007), 67 descendants of its own
- K082556: Clearcorrect (2009), 64 descendants of its own
- K113618: Clearcorrect System (2012), 60 descendants of its own
- K143630: Invisalign System (2015), 41 descendants of its own

## Indications for use
The Align System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars). The Align System positions teeth by way of continuous gentle force.

Source page: https://510kreport.com/device/K981095
Methodology: https://510kreport.com/methodology