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FDA 510(k)

Dental Implants and Abutments

K-Number: K161497 · 2016-10-28

ApplicantDitron Precision, Ltd.
Decision Date2016-10-28
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dental Implants and Abutments is a medical device manufactured by Ditron Precision, Ltd.. It received FDA 510(k) clearance on 2016-10-28 under approval number K161497. 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 2016-10-28. It is manufactured by Ditron Precision, Ltd.. The 510(k) number is K161497.

When was Dental Implants and Abutments approved by the FDA?

Dental Implants and Abutments received FDA 510(k) clearance on 2016-10-28, under approval number K161497.

What company makes Dental Implants and Abutments?

Dental Implants and Abutments is manufactured by Ditron Precision, 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

Related Devices (Code: DZE)

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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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