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FDA 510(k)

BLUEDIAMOND IMPLANT, Abutment Screw

K-Number: K211812 · 2023-01-06

ApplicantMegagen Implant Co., Ltd.
Decision Date2023-01-06
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BLUEDIAMOND IMPLANT, Abutment Screw is a medical device manufactured by Megagen Implant Co., Ltd.. It received FDA 510(k) clearance on 2023-01-06 under approval number K211812. 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 BLUEDIAMOND IMPLANT, Abutment Screw?

BLUEDIAMOND IMPLANT, Abutment Screw is a medical device that received FDA 510(k) clearance on 2023-01-06. It is manufactured by Megagen Implant Co., Ltd.. The 510(k) number is K211812.

When was BLUEDIAMOND IMPLANT, Abutment Screw approved by the FDA?

BLUEDIAMOND IMPLANT, Abutment Screw received FDA 510(k) clearance on 2023-01-06, under approval number K211812.

What company makes BLUEDIAMOND IMPLANT, Abutment Screw?

BLUEDIAMOND IMPLANT, Abutment Screw is manufactured by Megagen Implant Co., Ltd..

What is the FDA product code for BLUEDIAMOND IMPLANT, Abutment Screw?

The FDA product code for BLUEDIAMOND IMPLANT, Abutment Screw is DZE.

Related Clinical Trials

NCT07588789 The Aim of the Study Will be Clinically and Radio Graphically Comparison of Two Implant Designs Used to Treat Atrophied Mandible . Implant Design Comparison Will Done for Implant Stability,Peri-implant Soft Tissue Health Changes and Bone Changes .Patients Will be Divided Randomly Into Two Group ACTIVE_NOT_RECRUITING NCT07246499 Multicentre Study on the Impact of Transmucosal Abutment Surface Characteristics on Peri-implant Tissues. ACTIVE_NOT_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT05883202 Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants SUSPENDED NCT04695899 Zirconia Implants for Replacement of a Single Tooth ACTIVE_NOT_RECRUITING NCT06636136 Transtibial Osseointegration RECRUITING

Other Devices by Megagen Implant Co., Ltd.

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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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