Cleared Traditional

EQ-M

K210475 · Meta Systems Co., Ltd. · Dental

Sep 2022

Decision

581d

Days

Class 1

Risk

About This 510(k) Submission

K210475 is an FDA 510(k) clearance for the EQ-M, a Handpiece, Direct Drive, Ac-powered (Class I — General Controls, product code EKX), submitted by Meta Systems Co., Ltd. (Seongnam-Si, KR). The FDA issued a Cleared decision on September 21, 2022, 581 days after receiving the submission on February 17, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number	K210475 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 17, 2021
Decision Date	September 21, 2022
Days to Decision	581 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF