SMILERS— 510(k) K212961

Substantially Equivalent

Biotech Dental Smilers, Sas

FDA 510(k) clearance K212961 for SMILERS, Substantially Equivalent on 2021-09-20. Applicant: Biotech Dental Smilers, Sas.

Clearance details

Applicant: Biotech Dental Smilers, Sas
Product code: Code NXC
Advisory panel: Dental
Date received: 2021-09-16
Decision date: 2021-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salon De Provence, FR

Download summary PDF View 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, 2020-01-01 through 2026-04-23. 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.