# K780619: Preformed Tooth Positioner

- Pathway: 510(k) (Traditional)
- Applicant: Tp Laboratories, Inc.
- Decided: Jun 28, 1978 after 76 days
- Product code: KMY (Positioner, Tooth, Preformed)
- Device class: 1
- Regulation: 21 CFR 872.5525
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
136 later devices descend from it; 1 cites 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K981095: Align System (1998), 135 descendants of its own
- 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

Source page: https://510kreport.com/device/K780619
Methodology: https://510kreport.com/methodology