Cleared Traditional

Smooth Drive contra angle and straight handpieces

K220874 · Lares Research · Dental

Nov 2022

Decision

227d

Days

Class 1

Risk

About This 510(k) Submission

K220874 is an FDA 510(k) clearance for the Smooth Drive contra angle and straight handpieces, a Handpiece, Contra- And Right-angle Attachment, Dental (Class I — General Controls, product code EGS), submitted by Lares Research (Chico, US). The FDA issued a Cleared decision on November 7, 2022, 227 days after receiving the submission on March 25, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number	K220874 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 25, 2022
Decision Date	November 07, 2022
Days to Decision	227 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF