Cleared Traditional

BOMEDENT Apex locator, WISMY Apex locator

K203836 · Changzhou Bomedent Medical Technology Co.,Ltd · Dental

Mar 2021

Decision

90d

Days

—

Risk

About This 510(k) Submission

K203836 is an FDA 510(k) clearance for the BOMEDENT Apex locator, WISMY Apex locator, a Locator, Root Apex, submitted by Changzhou Bomedent Medical Technology Co.,Ltd (Changzhou, CN). The FDA issued a Cleared decision on March 30, 2021, 90 days after receiving the submission on December 30, 2020. This device falls under the Dental review panel.

Submission Details

510(k) Number	K203836 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 30, 2020
Decision Date	March 30, 2021
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF