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FDA 510(k)

Dental Implants OKTAGON Tissue Level and Bone Level

K-Number: K162073 · 2017-02-24

ApplicantHager& Meisinger GmbH
Decision Date2017-02-24
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dental Implants OKTAGON Tissue Level and Bone Level is a medical device manufactured by Hager& Meisinger GmbH. It received FDA 510(k) clearance on 2017-02-24 under approval number K162073. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dental Implants OKTAGON Tissue Level and Bone Level?

Dental Implants OKTAGON Tissue Level and Bone Level is a medical device that received FDA 510(k) clearance on 2017-02-24. It is manufactured by Hager& Meisinger GmbH. The 510(k) number is K162073.

When was Dental Implants OKTAGON Tissue Level and Bone Level approved by the FDA?

Dental Implants OKTAGON Tissue Level and Bone Level received FDA 510(k) clearance on 2017-02-24, under approval number K162073.

What company makes Dental Implants OKTAGON Tissue Level and Bone Level?

Dental Implants OKTAGON Tissue Level and Bone Level is manufactured by Hager& Meisinger GmbH.

What is the FDA product code for Dental Implants OKTAGON Tissue Level and Bone Level?

The FDA product code for Dental Implants OKTAGON Tissue Level and Bone Level is DZE.

Related Clinical Trials

NCT05362370 Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness ACTIVE_NOT_RECRUITING NCT07608939 Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers NOT_YET_RECRUITING NCT07608406 Modified Versus Clear Twin Block for Skeletal Class II Malocclusion NOT_YET_RECRUITING NCT07608523 Marginal Bone Level Around Dental Implants in Periodontitis Patients COMPLETED NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT07489820 Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41453025 Characterization and Time-delay in Issuing High-risk Recalls of Orthopaedic Devices From 2002 to 2023. The Journal of the American Academy of Orthopaedic Surgeons (2025) PMID: 41273038 Optimization of the Nonclinical Biological Evaluation of Medical Devices Using Toxicologic Pathology Best Practices. Advanced healthcare materials (2026) PMID: 40528079 The Challenges in the Regulatory Approval of Additive-Manufactured Medical Devices: A Quantitative Survey. Therapeutic innovation & regulatory science (2025)

Other Devices by Hager& Meisinger GmbH

K160132Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone Level NC K170287Dental Implants OKTAGON Bone Level Tapered Design K173819MyPlant II Implant System K180360OKTAGON Implant System K201210The Micro Screw System, Micro Screw System Basic K240321MP Pin flat without thread (36BMP000020/MP20)

View all 8 devices →

Related Devices (Code: DZE)

K160475Ritter Dental Implant SystemRitter Implants GmbH & Co. KG K161244s-Clean OneQ-SL Narrow Implant SystemDentis Co., Ltd. K163043Zeramex P6 Dental Implant SystemDentalpoint AG K161497Dental Implants and AbutmentsDitron Precision, Ltd. K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc. K151970KJ Mini Implant SystemKj Meditech Co., Ltd.

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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