HF-Etchant Hydrofluoric Acid Etching Gel
K-Number: K242530 · 2024-12-20
Decision Date2024-12-20
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
HF-Etchant Hydrofluoric Acid Etching Gel is a medical device manufactured by Rizhao Huge Biomaterials Company, Ltd.. It received FDA 510(k) clearance on 2024-12-20 under approval number K242530. 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 HF-Etchant Hydrofluoric Acid Etching Gel?
HF-Etchant Hydrofluoric Acid Etching Gel is a medical device that received FDA 510(k) clearance on 2024-12-20. It is manufactured by Rizhao Huge Biomaterials Company, Ltd.. The 510(k) number is K242530.
When was HF-Etchant Hydrofluoric Acid Etching Gel approved by the FDA?
HF-Etchant Hydrofluoric Acid Etching Gel received FDA 510(k) clearance on 2024-12-20, under approval number K242530.
What company makes HF-Etchant Hydrofluoric Acid Etching Gel?
HF-Etchant Hydrofluoric Acid Etching Gel is manufactured by Rizhao Huge Biomaterials Company, Ltd..
What is the FDA product code for HF-Etchant Hydrofluoric Acid Etching Gel?
The FDA product code for HF-Etchant Hydrofluoric 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.