Cleared Traditional

Primeprint Direct Aligner

K250739 · Dreve Dentamid GmbH · Dental
Nov 2025
Decision
241d
Days
Class 2
Risk

About This 510(k) Submission

K250739 is an FDA 510(k) clearance for the Primeprint Direct Aligner, a Aligner, Sequential (Class II — Special Controls, product code NXC), submitted by Dreve Dentamid GmbH (Unna, DE). The FDA issued a Cleared decision on November 7, 2025, 241 days after receiving the submission on March 11, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number K250739 FDA.gov
FDA Decision Cleared SESE
Date Received March 11, 2025
Decision Date November 07, 2025
Days to Decision 241 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code NXC — Aligner, Sequential
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.5470
Definition The Device Moves The Teeth By Continuous Gentle Force For Treatment Of Minor Tooth Malocclusion.