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FDA 510(k)

PYRAMIDION Dental Implants and Prostheses

K-Number: K180859 · 2018-12-13

ApplicantDentack Implants, Ltd.
Decision Date2018-12-13
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PYRAMIDION Dental Implants and Prostheses is a medical device manufactured by Dentack Implants, Ltd.. It received FDA 510(k) clearance on 2018-12-13 under approval number K180859. 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 PYRAMIDION Dental Implants and Prostheses?

PYRAMIDION Dental Implants and Prostheses is a medical device that received FDA 510(k) clearance on 2018-12-13. It is manufactured by Dentack Implants, Ltd.. The 510(k) number is K180859.

When was PYRAMIDION Dental Implants and Prostheses approved by the FDA?

PYRAMIDION Dental Implants and Prostheses received FDA 510(k) clearance on 2018-12-13, under approval number K180859.

What company makes PYRAMIDION Dental Implants and Prostheses?

PYRAMIDION Dental Implants and Prostheses is manufactured by Dentack Implants, Ltd..

What is the FDA product code for PYRAMIDION Dental Implants and Prostheses?

The FDA product code for PYRAMIDION Dental Implants and Prostheses is DZE.

Related Clinical Trials

NCT07608523 Marginal Bone Level Around Dental Implants in Periodontitis Patients COMPLETED NCT07605286 Soft Tissue Augmentation Around Dental Implants COMPLETED NCT07589140 Influence of Alveolar Bone Drilling and Anatomical Position on Integration NOT_YET_RECRUITING NCT07246499 Multicentre Study on the Impact of Transmucosal Abutment Surface Characteristics on Peri-implant Tissues. ACTIVE_NOT_RECRUITING NCT07240493 BMP Effect on Implant Stability and Marginal Bone Level After Immediate Placement COMPLETED NCT05883202 Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants SUSPENDED

Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026)

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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