Primeprint Direct Aligner
K-Number: K250739 · 2025-11-07
ApplicantDreve Dentamid GmbH
Decision Date2025-11-07
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Primeprint Direct Aligner is a medical device manufactured by Dreve Dentamid GmbH. It received FDA 510(k) clearance on 2025-11-07 under approval number K250739. 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 Primeprint Direct Aligner?
Primeprint Direct Aligner is a medical device that received FDA 510(k) clearance on 2025-11-07. It is manufactured by Dreve Dentamid GmbH. The 510(k) number is K250739.
When was Primeprint Direct Aligner approved by the FDA?
Primeprint Direct Aligner received FDA 510(k) clearance on 2025-11-07, under approval number K250739.
What company makes Primeprint Direct Aligner?
Primeprint Direct Aligner is manufactured by Dreve Dentamid GmbH.
What is the FDA product code for Primeprint Direct Aligner?
The FDA product code for Primeprint Direct Aligner 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.