HC Primer
K-Number: K161891 · 2016-11-21
ApplicantShofu Dental Corporation
Decision Date2016-11-21
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
HC Primer is a medical device manufactured by Shofu Dental Corporation. It received FDA 510(k) clearance on 2016-11-21 under approval number K161891. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the HC Primer?
HC Primer is a medical device that received FDA 510(k) clearance on 2016-11-21. It is manufactured by Shofu Dental Corporation. The 510(k) number is K161891.
When was HC Primer approved by the FDA?
HC Primer received FDA 510(k) clearance on 2016-11-21, under approval number K161891.
What company makes HC Primer?
HC Primer is manufactured by Shofu Dental Corporation.
What is the FDA product code for HC Primer?
The FDA product code for HC Primer is KLE.
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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.