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FDA 510(k)

Dentsply Sirona Universal Spray Glazes

K-Number: K202629 · 2021-01-20

ApplicantDentsply Sirona
Decision Date2021-01-20
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dentsply Sirona Universal Spray Glazes is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona. It received FDA 510(k) clearance on 2021-01-20 under 510(k) number K202629. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dentsply Sirona Universal Spray Glazes?

Dentsply Sirona Universal Spray Glazes is a medical device that received FDA 510(k) clearance on 2021-01-20. The listed applicant is Dentsply Sirona. The 510(k) number is K202629.

When did Dentsply Sirona Universal Spray Glazes receive FDA 510(k) clearance?

Dentsply Sirona Universal Spray Glazes received FDA 510(k) clearance on 2021-01-20, under 510(k) number K202629.

Who is the listed applicant for Dentsply Sirona Universal Spray Glazes?

The FDA 510(k) record lists Dentsply Sirona as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dentsply Sirona Universal Spray Glazes?

The FDA product code for Dentsply Sirona Universal Spray Glazes is EIH.

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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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