Smooth Drive contra angle and straight handpieces— 510(k) K220874

Substantially Equivalent

Lares Research

FDA 510(k) clearance K220874 for Smooth Drive contra angle and straight handpieces, Substantially Equivalent on 2022-11-07. Applicant: Lares Research.

Clearance details

Applicant
Lares Research
Product code
Code EGS
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Chico, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code EGS

product code EGS
Injury
356
Malfunction
759
Total
1,115

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.