Cleared Traditional

K250739 - Primeprint Direct Aligner (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250739 · Dreve Dentamid GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2025
Decision
241d
Days
Class 2
Risk

K250739 is an FDA 510(k) clearance for the Primeprint Direct Aligner. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Dreve Dentamid GmbH (Unna, DE). The FDA issued a Cleared decision on November 7, 2025 after a review of 241 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5470 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Dreve Dentamid GmbH devices

Submission Details

510(k) Number K250739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
114d slower than avg
Panel avg: 127d · This submission: 241d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NXC Aligner, Sequential
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5470
Definition The Device Moves The Teeth By Continuous Gentle Force For Treatment Of Minor Tooth Malocclusion.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - NXC Aligner, Sequential

All 142
Devices cleared under the same product code (NXC) and FDA review panel - the closest regulatory comparables to K250739.
SureSmile Aligner (ASSY500020)
K260722 · Dentsply Sirona, Inc. · Apr 2026
ZSmile System
K253282 · Dror Orthodesign , Ltd. · Feb 2026
Clear Aligner (SCF-3348)
K251454 · Beame Medical Technology (Shenzhen) Limited · Jan 2026
Invisalign® Palatal Expander System
K252931 · Align Technology, Inc. · Oct 2025
Invisalign Specifix Attachment System
K252870 · Align Technology, Inc. · Oct 2025
Serafin®
K251758 · Tns Co., Ltd. · Sep 2025