TopCEM-Try in Veneer Try-in Gel
K-Number: K242572 · 2024-12-20
Decision Date2024-12-20
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
TopCEM-Try in Veneer Try-in 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 K242572. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TopCEM-Try in Veneer Try-in Gel?
TopCEM-Try in Veneer Try-in 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 K242572.
When was TopCEM-Try in Veneer Try-in Gel approved by the FDA?
TopCEM-Try in Veneer Try-in Gel received FDA 510(k) clearance on 2024-12-20, under approval number K242572.
What company makes TopCEM-Try in Veneer Try-in Gel?
TopCEM-Try in Veneer Try-in Gel is manufactured by Rizhao Huge Biomaterials Company, Ltd..
What is the FDA product code for TopCEM-Try in Veneer Try-in Gel?
The FDA product code for TopCEM-Try in Veneer Try-in Gel is EBF.
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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.