K242715
- 510(k) number
- K242715
- Device name
- Pearl Clear Aligner
- Applicant
- Pearl Digital, Inc. CA · US
- Product code
- NXC — Aligner, Sequential
- Decision date
- 2025-01-16
- Date received
- 2024-09-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
510(k) Summary (official FDA PDF): K242715.pdf
Official FDA record: K242715
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.