Clear Moves Aligners— 510(k) K240038

Substantially Equivalent

Space Maintainers Laboratories (Sml)

FDA 510(k) clearance K240038 for Clear Moves Aligners, Substantially Equivalent on 2024-04-04. Applicant: Space Maintainers Laboratories (Sml).

Clearance details

Applicant
Space Maintainers Laboratories (Sml)
Product code
Code NXC
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Chatsworth, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code NXC

product code NXC
Injury
15,206
Malfunction
2,576
Other
9
Total
17,791

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.