EtchPro Etching Gel
K-Number: K200462 · 2020-09-02
ApplicantBelport Company, Inc., Gingi-Pak
Decision Date2020-09-02
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
EtchPro Etching Gel is a medical device manufactured by Belport Company, Inc., Gingi-Pak. It received FDA 510(k) clearance on 2020-09-02 under approval number K200462. 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 EtchPro Etching Gel?
EtchPro Etching Gel is a medical device that received FDA 510(k) clearance on 2020-09-02. It is manufactured by Belport Company, Inc., Gingi-Pak. The 510(k) number is K200462.
When was EtchPro Etching Gel approved by the FDA?
EtchPro Etching Gel received FDA 510(k) clearance on 2020-09-02, under approval number K200462.
What company makes EtchPro Etching Gel?
EtchPro Etching Gel is manufactured by Belport Company, Inc., Gingi-Pak.
What is the FDA product code for EtchPro Etching Gel?
The FDA product code for EtchPro Etching Gel 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.