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FDA 510(k)

Surefil one Self-adhesive Composite Hybrid

K-Number: K192530 · 2020-01-23

ApplicantDentsply Sirona
Decision Date2020-01-23
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Surefil one Self-adhesive Composite Hybrid is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona. It received FDA 510(k) clearance on 2020-01-23 under 510(k) number K192530. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Surefil one Self-adhesive Composite Hybrid?

Surefil one Self-adhesive Composite Hybrid is a medical device that received FDA 510(k) clearance on 2020-01-23. The listed applicant is Dentsply Sirona. The 510(k) number is K192530.

When did Surefil one Self-adhesive Composite Hybrid receive FDA 510(k) clearance?

Surefil one Self-adhesive Composite Hybrid received FDA 510(k) clearance on 2020-01-23, under 510(k) number K192530.

Who is the listed applicant for Surefil one Self-adhesive Composite Hybrid?

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 Surefil one Self-adhesive Composite Hybrid?

The FDA product code for Surefil one Self-adhesive Composite Hybrid is EMA.

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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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