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 a medical device manufactured by Dentsply Sirona. It received FDA 510(k) clearance on 2022-02-17 under approval 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. It is manufactured by Dentsply Sirona. The 510(k) number is K211212.
When was LoFric Elle approved by the FDA?
LoFric Elle received FDA 510(k) clearance on 2022-02-17, under approval number K211212.
What company makes LoFric Elle?
LoFric Elle is manufactured by Dentsply Sirona.
What is the FDA product code for LoFric Elle?
The FDA product code for LoFric Elle is 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.