Dental Implant Unit— 510(k) K242646

Name: FDA 510(k) clearance K242646
Creator: U.S. Food and Drug Administration
Published: 2025-04-11

Substantially Equivalent

Guilin Aesthedent Medical Instruments Co., Ltd.

FDA 510(k) clearance K242646 for Dental Implant Unit, Substantially Equivalent on 2025-04-11. Applicant: Guilin Aesthedent Medical Instruments Co., Ltd.. Device class: 1.

Clearance details

Applicant: Guilin Aesthedent Medical Instruments Co., Ltd.
Product code: Code EBW
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2024-09-03
Decision date: 2025-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guilin, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBW

view all

K251407 — Motor Handpiece and Control Unit (SDI10)2026-01-30
K251701 — Star E900 Electric System2026-01-12
K251811 — Motor and Apex Module (MaAM)2025-08-25
K231562 — ELEC ENGINE (Model: ISE-170L)2025-07-18
K233288 — NLZ Built-In Motor System2024-06-24

Data sourced from openFDA. This site is unofficial and independent of the FDA.