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FDA 510(k)

Halley resin

K-Number: K190043 · 2019-04-24

ApplicantDentsply Sirona
Decision Date2019-04-24
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Halley resin is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona. It received FDA 510(k) clearance on 2019-04-24 under 510(k) number K190043. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Halley resin?

Halley resin is a medical device that received FDA 510(k) clearance on 2019-04-24. The listed applicant is Dentsply Sirona. The 510(k) number is K190043.

When did Halley resin receive FDA 510(k) clearance?

Halley resin received FDA 510(k) clearance on 2019-04-24, under 510(k) number K190043.

Who is the listed applicant for Halley resin?

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 Halley resin?

The FDA product code for Halley resin is EBI.

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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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