Phosphoric Acid Etching Gel
K-Number: K221450 · 2022-09-12
Decision Date2022-09-12
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Phosphoric Acid Etching Gel is a medical device manufactured by Rizhao Huge Biomaterials Company, Ltd.. It received FDA 510(k) clearance on 2022-09-12 under approval number K221450. 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 Phosphoric Acid Etching Gel?
Phosphoric Acid Etching Gel is a medical device that received FDA 510(k) clearance on 2022-09-12. It is manufactured by Rizhao Huge Biomaterials Company, Ltd.. The 510(k) number is K221450.
When was Phosphoric Acid Etching Gel approved by the FDA?
Phosphoric Acid Etching Gel received FDA 510(k) clearance on 2022-09-12, under approval number K221450.
What company makes Phosphoric Acid Etching Gel?
Phosphoric Acid Etching Gel is manufactured by Rizhao Huge Biomaterials Company, Ltd..
What is the FDA product code for Phosphoric Acid Etching Gel?
The FDA product code for Phosphoric Acid 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.