Cleared Traditional

Dental Implant Unit

K242646 · Guilin Aesthedent Medical Instruments Co., Ltd. · Dental

Apr 2025

Decision

220d

Days

Class 1

Risk

About This 510(k) Submission

K242646 is an FDA 510(k) clearance for the Dental Implant Unit, a Controller, Foot, Handpiece And Cord (Class I — General Controls, product code EBW), submitted by Guilin Aesthedent Medical Instruments Co., Ltd. (Guilin, CN). The FDA issued a Cleared decision on April 11, 2025, 220 days after receiving the submission on September 3, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number	K242646 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 03, 2024
Decision Date	April 11, 2025
Days to Decision	220 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF