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FDA 510(k)

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

K-Number: K160132 · 2016-11-21

ApplicantHager& Meisinger GmbH
Decision Date2016-11-21
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

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.

NCT07636265The Effect Of Photobiomodulation On Dental Implant SurvivalCOMPLETEDNCT07714265Soft Tissue Augmentation Around Dental Implants Using Connective Tissue Graft, Submerged Tenting Abutment, or Sub-crestal Implant PlacementRECRUITINGNCT05883202Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental ImplantsSUSPENDEDNCT07240493BMP Effect on Implant Stability and Marginal Bone Level After Immediate PlacementCOMPLETEDNCT07529444Microbiological Evaluation of the Effectiveness of Different Surface Decontamination Protocols for Dental ImplantsRECRUITINGNCT07633912Local Factors in the Onset/Progression of Peri-implantitis: A Retrospective StudyCOMPLETED

Other records listing Hager& Meisinger GmbH as applicant

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.

K250123Master-Pin X (MP Pin with thread) (36BMP000030 / MP30)K240321MP Pin flat without thread (36BMP000020/MP20)K201210The Micro Screw System, Micro Screw System BasicK173819MyPlant II Implant SystemK180360OKTAGON Implant SystemK170287Dental Implants OKTAGON Bone Level Tapered Design

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Related Devices (Code: NHA)

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.

K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLCK260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLCK260564DESS Dental Smart SolutionsTerrats Medical SL

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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