# K994357: Bitem Lock, Models SW006, SW012

- Pathway: 510(k) (Traditional)
- Applicant: Thermoelastic Technologies, Inc.
- Decided: Mar 14, 2000 after 78 days
- Product code: EJF (Bracket, Metal, Orthodontic)
- Device class: 1
- Regulation: 21 CFR 872.5410
- 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 K900678 (1990). 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)
- K900678: The Myoloc System, Winder Research, Inc. (1990) Summary page 1.

## Indications for use
intended for Use as an aligning bracket for removable dentures, and to aid in securing dentures.

Source page: https://510kreport.com/device/K994357
Methodology: https://510kreport.com/methodology