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FDA 510(k)

Dental Implants and Abutments

K-Number: K243066 · 2024-12-16

ApplicantDitron Dental, Ltd.
Decision Date2024-12-16
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dental Implants and Abutments is a medical device manufactured by Ditron Dental, Ltd.. It received FDA 510(k) clearance on 2024-12-16 under approval number K243066. 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 and Abutments?

Dental Implants and Abutments is a medical device that received FDA 510(k) clearance on 2024-12-16. It is manufactured by Ditron Dental, Ltd.. The 510(k) number is K243066.

When was Dental Implants and Abutments approved by the FDA?

Dental Implants and Abutments received FDA 510(k) clearance on 2024-12-16, under approval number K243066.

What company makes Dental Implants and Abutments?

Dental Implants and Abutments is manufactured by Ditron Dental, Ltd..

What is the FDA product code for Dental Implants and Abutments?

The FDA product code for Dental Implants and Abutments 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

Other Devices by Ditron Dental, Ltd.

K233231Dental Implants and Abutments

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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