K-number	K250739
Device name	Primeprint Direct Aligner
Applicant	Dreve Dentamid GmbH
Product code	NXC
Device class	Class II
Decision date	Nov 7, 2025
Decision	Substantially Equivalent
Regulation	872.5470

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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Primeprint Direct Aligner

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