Cleared Traditional

Lotus Prophy Angle

K220346 · Ajk Engineering, Inc. · Dental

Nov 2022

Decision

273d

Days

Class 1

Risk

About This 510(k) Submission

K220346 is an FDA 510(k) clearance for the Lotus Prophy Angle, a Handpiece, Contra- And Right-angle Attachment, Dental (Class I — General Controls, product code EGS), submitted by Ajk Engineering, Inc. (Sommerville, US). The FDA issued a Cleared decision on November 7, 2022, 273 days after receiving the submission on February 7, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number	K220346 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 07, 2022
Decision Date	November 07, 2022
Days to Decision	273 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF