FDA 510(k)

Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone Level NC

Numéro K : K160132 · 2016-11-21

Date de décision2016-11-21

Code produitNHA

Comité consultatifDE

DécisionSubstantially Equivalent

Résumé du dispositif

Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone Level NC is the device name listed in this FDA 510(k) record. The listed applicant is Hager& Meisinger GmbH. It received FDA 510(k) clearance on 2016-11-21 under 510(k) number K160132. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone Level NC?

Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone Level NC is a medical device that received FDA 510(k) clearance on 2016-11-21. The listed applicant is Hager& Meisinger GmbH. The 510(k) number is K160132.

When did Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone Level NC receive FDA 510(k) clearance?

Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone Level NC received FDA 510(k) clearance on 2016-11-21, under 510(k) number K160132.

Who is the listed applicant for Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone Level NC?

The FDA 510(k) record lists Hager& Meisinger GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone Level NC?

The FDA product code for Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone Level NC is NHA.

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 Hager& Meisinger GmbH en tant que demandeur

K250123Master-Pin X (MP Pin with thread) (36BMP000030 / MP30)K240321MP Pin flat without thread (36BMP000020/MP20)K201210The Micro Screw System, Micro Screw System Basic K173819MyPlant II Implant System K180360OKTAGON Implant System K170287Dental Implants OKTAGON Bone Level Tapered Design

Voir tous les 8 dispositifs →

Dispositifs connexes (Code : NHA)

K262207Cemented Plus AbutmentUnidental Co., Ltd.K260940BellaTek BarsZimVie US Corp, LLC K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic ScrewNobel Biocare AB K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLC K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, 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.