Additively Manufactured Aligner Resin
K-Number: K251415 · 2025-08-27
Decision Date2025-08-27
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Additively Manufactured Aligner Resin is a medical device manufactured by Aidite (Qinhuangdao) Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-08-27 under approval number K251415. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Additively Manufactured Aligner Resin?
Additively Manufactured Aligner Resin is a medical device that received FDA 510(k) clearance on 2025-08-27. It is manufactured by Aidite (Qinhuangdao) Technology Co., Ltd.. The 510(k) number is K251415.
When was Additively Manufactured Aligner Resin approved by the FDA?
Additively Manufactured Aligner Resin received FDA 510(k) clearance on 2025-08-27, under approval number K251415.
What company makes Additively Manufactured Aligner Resin?
Additively Manufactured Aligner Resin is manufactured by Aidite (Qinhuangdao) Technology Co., Ltd..
What is the FDA product code for Additively Manufactured Aligner Resin?
The FDA product code for Additively Manufactured Aligner Resin is NXC.
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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.