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FDA 510(k)

Sirona Dental CAD/CAM System with InLab Software

K-Number: K200191 · 2020-08-19

ApplicantDentsply Sirona
Decision Date2020-08-19
Product CodePNP
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Sirona Dental CAD/CAM System with InLab Software is a medical device manufactured by Dentsply Sirona. It received FDA 510(k) clearance on 2020-08-19 under approval number K200191. The device is classified under product code PNP. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sirona Dental CAD/CAM System with InLab Software?

Sirona Dental CAD/CAM System with InLab Software is a medical device that received FDA 510(k) clearance on 2020-08-19. It is manufactured by Dentsply Sirona. The 510(k) number is K200191.

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

Sirona Dental CAD/CAM System with InLab Software received FDA 510(k) clearance on 2020-08-19, under approval number K200191.

What company makes Sirona Dental CAD/CAM System with InLab Software?

Sirona Dental CAD/CAM System with InLab Software is manufactured by Dentsply Sirona.

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

The FDA product code for Sirona Dental CAD/CAM System with InLab Software is PNP.

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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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