Denture Base Resin
K-Number: K230115 · 2023-03-17
Decision Date2023-03-17
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Denture Base Resin is a medical device manufactured by Aidite (Qinhuangdao) Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-03-17 under approval number K230115. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Denture Base Resin?
Denture Base Resin is a medical device that received FDA 510(k) clearance on 2023-03-17. It is manufactured by Aidite (Qinhuangdao) Technology Co., Ltd.. The 510(k) number is K230115.
When was Denture Base Resin approved by the FDA?
Denture Base Resin received FDA 510(k) clearance on 2023-03-17, under approval number K230115.
What company makes Denture Base Resin?
Denture Base Resin is manufactured by Aidite (Qinhuangdao) Technology Co., Ltd..
What is the FDA product code for Denture Base Resin?
The FDA product code for Denture Base Resin is EBI.
Other Devices by Aidite (Qinhuangdao) Technology Co., Ltd.
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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.