# K242715: Pearl Clear Aligner

- Pathway: 510(k) (Traditional)
- Applicant: Pearl Digital, Inc.
- Decided: Jan 16, 2025 after 128 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Invisalign Clear Aligner: named in the summary without a submission number

## Indications for use
The Pearl Clear Aligner is indicated for the alignment of teeth during orthodontic treatment of malocclusions by continuous gentle forces.

Source page: https://510kreport.com/device/K242715
Methodology: https://510kreport.com/methodology