SHOFU MZ Primer Plus
K-Number: K172106 · 2017-08-31
ApplicantShofu Dental Corporation
Decision Date2017-08-31
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
SHOFU MZ Primer Plus is a medical device manufactured by Shofu Dental Corporation. It received FDA 510(k) clearance on 2017-08-31 under approval number K172106. 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 SHOFU MZ Primer Plus?
SHOFU MZ Primer Plus is a medical device that received FDA 510(k) clearance on 2017-08-31. It is manufactured by Shofu Dental Corporation. The 510(k) number is K172106.
When was SHOFU MZ Primer Plus approved by the FDA?
SHOFU MZ Primer Plus received FDA 510(k) clearance on 2017-08-31, under approval number K172106.
What company makes SHOFU MZ Primer Plus?
SHOFU MZ Primer Plus is manufactured by Shofu Dental Corporation.
What is the FDA product code for SHOFU MZ Primer Plus?
The FDA product code for SHOFU MZ Primer Plus is KLE.
Other Devices by Shofu Dental Corporation
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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.