Dental Implant Unit

FDA 510(k) K242646 · Guilin Aesthedent Medical Instruments Co., Ltd.

Substantially Equivalent

510(k) numberK242646

Submission

Device name
Dental Implant Unit
Applicant
Guilin Aesthedent Medical Instruments Co., Ltd.
Guilin, CN
Received
September 3, 2024
Decision date
April 11, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EBW – Controller, Foot, Handpiece And Cord
Device class
Class I (low risk)
Regulation
21 CFR 872.4200
Specialty
Dental

Other 510(k)s with product code EBW

510(k)DeviceApplicantDecision
K251407Motor Handpiece and Control Unit (SDI10)EBW · Traditional Saeshin Precision Co., Ltd.01/30/2026SE
K251701Star E900 Electric SystemEBW · Traditional Dentalez, Inc., Stardental Division01/12/2026SE
K251811Motor and Apex Module (MaAM)EBW · Traditional Dentsply Sirona, Inc.08/25/2025SE
K231562ELEC ENGINE (Model: ISE-170L)EBW · Special Micro-Nx Co., Ltd.07/18/2025SE
K233288NLZ Built-In Motor SystemEBW · Traditional Nakanishi, Inc.06/24/2024SE
K233117Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)EBW · Traditional Nakanishi, Inc.06/20/2024SE
K230895CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3…EBW · Traditional Cefla S.C.04/01/2024SE
K231864Fiber Optic Brushless Electronic Micromotor, model: iM100EBW · Traditional Codent Technical Industry Co., Ltd.03/11/2024SE
K211358Implanter incl. AccessoriesEBW · Traditional Guilin Woodpecker Medical Instrument Co., Ltd.11/21/2022SE
K220831Dental Implantation Systems, Dental Electrical MotorsEBW · Traditional Foshan Coxo Medical Instrument Co., Ltd.09/27/2022SE

Questions and answers

When was Dental Implant Unit cleared by the FDA?

Dental Implant Unit (K242646) received a 510(k) decision of Substantially Equivalent on April 11, 2025, 220 days after the submission was received.

What is the product code of K242646?

The FDA product code is EBW – Controller, Foot, Handpiece And Cord, a Class I (low risk) device regulated under 21 CFR 872.4200.