FDA 510(k)

Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts

Numéro K : K192221 · 2020-06-25

DemandeurImplant Direct Sybron Manufacturing, LLC

Date de décision2020-06-25

Code produitDZE

Comité consultatifDE

DécisionSubstantially Equivalent

Résumé du dispositif

Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts is the device name listed in this FDA 510(k) record. The listed applicant is Implant Direct Sybron Manufacturing, LLC. It received FDA 510(k) clearance on 2020-06-25 under 510(k) number K192221. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts?

Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts is a medical device that received FDA 510(k) clearance on 2020-06-25. The listed applicant is Implant Direct Sybron Manufacturing, LLC. The 510(k) number is K192221.

When did Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts receive FDA 510(k) clearance?

Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts received FDA 510(k) clearance on 2020-06-25, under 510(k) number K192221.

Who is the listed applicant for Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts?

The FDA 510(k) record lists Implant Direct Sybron Manufacturing, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts?

The FDA product code for Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts is DZE.

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

Autres dossiers indiquant Implant Direct Sybron Manufacturing, LLC en tant que demandeur

K231087Guided Surgery Kit K223535SMARTbase Abutment System K222211Implant Direct Dental Implant Systems Portfolio - MR Conditional K202524Standard Sterilizable Tray K201553Simply Iconic Implants K200858Mini Sterilizable Tray

Voir tous les 13 dispositifs →

Dispositifs connexes (Code : DZE)

K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC K260463ZEROS Dental Implant SystemZeros Co., Ltd.K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, 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.