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FDA 510(k)

LoFric Elle

K-Number: K211212 · 2022-02-17

ApplicantDentsply Sirona
Decision Date2022-02-17
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LoFric Elle is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona. It received FDA 510(k) clearance on 2022-02-17 under 510(k) number K211212. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LoFric Elle?

LoFric Elle is a medical device that received FDA 510(k) clearance on 2022-02-17. The listed applicant is Dentsply Sirona. The 510(k) number is K211212.

When did LoFric Elle receive FDA 510(k) clearance?

LoFric Elle received FDA 510(k) clearance on 2022-02-17, under 510(k) number K211212.

Who is the listed applicant for LoFric Elle?

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 LoFric Elle?

The FDA product code for LoFric Elle is EZD.

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Related Devices (Code: EZD)

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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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