FDA 510(k)

Dental Implant Unit

Numéro K : K242646 · 2025-04-11

DemandeurGuilin Aesthedent Medical Instruments Co., Ltd.

Date de décision2025-04-11

Code produitEBW

Comité consultatifDE

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositifs connexes (Code : EBW)

K251407Motor Handpiece and Control Unit (SDI10)Saeshin Precision Co., Ltd.K251701Star E900 Electric SystemDentalez, Inc., Stardental Division K251811Motor 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.

Source officielle

Voir dans la base de données FDA →

Données issues de l'API ouverte de la FDA. Pour les informations les plus récentes et faisant autorité, veuillez toujours vous référer au registre officiel.