Fit SA
K-Number: K182869 · 2019-01-09
ApplicantShofu Dental Corporation
Decision Date2019-01-09
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Fit SA is a medical device manufactured by Shofu Dental Corporation. It received FDA 510(k) clearance on 2019-01-09 under approval number K182869. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Fit SA?
Fit SA is a medical device that received FDA 510(k) clearance on 2019-01-09. It is manufactured by Shofu Dental Corporation. The 510(k) number is K182869.
When was Fit SA approved by the FDA?
Fit SA received FDA 510(k) clearance on 2019-01-09, under approval number K182869.
What company makes Fit SA?
Fit SA is manufactured by Shofu Dental Corporation.
What is the FDA product code for Fit SA?
The FDA product code for Fit SA is EBF.
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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.