# K212961: Smilers

- Pathway: 510(k) (Traditional)
- Applicant: Biotech Dental Smilers, Sas
- Decided: Sep 20, 2021 after 4 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: 6 generations back to K780619 (1978). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180346: Byte Aligner System, Straight Smile, LLC (2019) Summary page 4.

## Indications for use
Biotech Dental SMILERS®aligners are indicated for the alignment of teeth in patients with permanent dentition (i.e., all second molars) during orthodontic treatment of malocclusion. SMILERS®aligners position teeth by way of continuous gentle force.

Source page: https://510kreport.com/device/K212961
Methodology: https://510kreport.com/methodology