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FDA 510(k)

Dental Implant Unit

K-Number: K242646 · 2025-04-11

ApplicantGuilin Aesthedent Medical Instruments Co., Ltd.
Decision Date2025-04-11
Product CodeEBW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dental Implant Unit is the device name listed in this FDA 510(k) record. The listed applicant is Guilin Aesthedent Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2025-04-11 under 510(k) number K242646. The device is classified under product code EBW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dental Implant Unit?

Dental Implant Unit is a medical device that received FDA 510(k) clearance on 2025-04-11. The listed applicant is Guilin Aesthedent Medical Instruments Co., Ltd.. The 510(k) number is K242646.

When did Dental Implant Unit receive FDA 510(k) clearance?

Dental Implant Unit received FDA 510(k) clearance on 2025-04-11, under 510(k) number K242646.

Who is the listed applicant for Dental Implant Unit?

The FDA 510(k) record lists Guilin Aesthedent Medical Instruments Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dental Implant Unit?

The FDA product code for Dental Implant Unit is EBW.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05883202Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental ImplantsSUSPENDED

Related Devices (Code: EBW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251407Motor Handpiece and Control Unit (SDI10)Saeshin Precision Co., Ltd.K251701Star E900 Electric SystemDentalez, Inc., Stardental DivisionK251811Motor and Apex Module (MaAM)Dentsply Sirona, Inc.K231562ELEC ENGINE (Model: ISE-170L)Micro-Nx Co., Ltd.K233288NLZ Built-In Motor SystemNakanishi, Inc.K233117Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)Nakanishi, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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