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FDA 510(k)

CEREC Ortho Software

K-Number: K171122 · 2018-01-11

ApplicantDentsply Sirona
Decision Date2018-01-11
Product CodePNN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CEREC Ortho Software is a medical device manufactured by Dentsply Sirona. It received FDA 510(k) clearance on 2018-01-11 under approval number K171122. The device is classified under product code PNN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CEREC Ortho Software?

CEREC Ortho Software is a medical device that received FDA 510(k) clearance on 2018-01-11. It is manufactured by Dentsply Sirona. The 510(k) number is K171122.

When was CEREC Ortho Software approved by the FDA?

CEREC Ortho Software received FDA 510(k) clearance on 2018-01-11, under approval number K171122.

What company makes CEREC Ortho Software?

CEREC Ortho Software is manufactured by Dentsply Sirona.

What is the FDA product code for CEREC Ortho Software?

The FDA product code for CEREC Ortho Software is PNN.

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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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