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FDA 510(k)

DS Implants abutments provided with the EV connection

K-Number: K213449 · 2021-11-15

ApplicantDentsply Sirona
Decision Date2021-11-15
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DS Implants abutments provided with the EV connection is a medical device manufactured by Dentsply Sirona. It received FDA 510(k) clearance on 2021-11-15 under approval number K213449. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DS Implants abutments provided with the EV connection?

DS Implants abutments provided with the EV connection is a medical device that received FDA 510(k) clearance on 2021-11-15. It is manufactured by Dentsply Sirona. The 510(k) number is K213449.

When was DS Implants abutments provided with the EV connection approved by the FDA?

DS Implants abutments provided with the EV connection received FDA 510(k) clearance on 2021-11-15, under approval number K213449.

What company makes DS Implants abutments provided with the EV connection?

DS Implants abutments provided with the EV connection is manufactured by Dentsply Sirona.

What is the FDA product code for DS Implants abutments provided with the EV connection?

The FDA product code for DS Implants abutments provided with the EV connection is NHA.

Related Clinical Trials

NCT07246499 Multicentre Study on the Impact of Transmucosal Abutment Surface Characteristics on Peri-implant Tissues. ACTIVE_NOT_RECRUITING NCT05883202 Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants SUSPENDED NCT05859113 Evaluation of Marginal Bone Loss and Associated Factors Around Ziacom Dental Implants With Different Prosthetic Connection ACTIVE_NOT_RECRUITING NCT07500961 Novel Bone Substitute (ALBO-OS) in Patients With Periodontal Disease or Who Need Alveolar Preservation COMPLETED

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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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