# K182388: Krystal Klear Aligners

- Pathway: 510(k) (Traditional)
- Applicant: Shatkin F.I.R.S.T., LLC
- Decided: Dec 19, 2019 after 471 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: 3 generations back to K780619 (1978). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071970: Clear Image Aligner, Specialty Appliance Works, Inc. (2007) Summary page 4.

## Indications for use
The Krystal Klear 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 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/K182388
Methodology: https://510kreport.com/methodology