# K210540: Ohlendorf Clear Aligner

- Pathway: 510(k) (Traditional)
- Applicant: Ohlendorf Appliance Laboratory
- Decided: May 19, 2021 after 84 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: 5 generations back to K780619 (1978). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182826: Ormco Spark Aligner System, Sybron Dental Specialties (2018) Summary page 7.

## Most influential descendants
- K241137: Clear Moves Aligner (2024), 0 descendants of its own

## Indications for use
Ohlendorf Clear Aligner is indicated for the alignment of teeth during orthodontic treatment of malocclusion in patients with permanent dentition (i.e. all second molars). The Ohlendorf Clear Alginer positions teeth by way of continuous gentle force.

Source page: https://510kreport.com/device/K210540
Methodology: https://510kreport.com/methodology