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FDA 510(k)

Sirona Dental CAD/CAM System

K-Number: K181520 · 2018-10-11

ApplicantDentsply Sirona
Decision Date2018-10-11
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Sirona Dental CAD/CAM System is a medical device manufactured by Dentsply Sirona. It received FDA 510(k) clearance on 2018-10-11 under approval number K181520. 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 Sirona Dental CAD/CAM System?

Sirona Dental CAD/CAM System is a medical device that received FDA 510(k) clearance on 2018-10-11. It is manufactured by Dentsply Sirona. The 510(k) number is K181520.

When was Sirona Dental CAD/CAM System approved by the FDA?

Sirona Dental CAD/CAM System received FDA 510(k) clearance on 2018-10-11, under approval number K181520.

What company makes Sirona Dental CAD/CAM System?

Sirona Dental CAD/CAM System is manufactured by Dentsply Sirona.

What is the FDA product code for Sirona Dental CAD/CAM System?

The FDA product code for Sirona Dental CAD/CAM System is NHA.

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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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