Primeprint Direct Aligner— 510(k) K250739

Name: FDA 510(k) clearance K250739
Creator: U.S. Food and Drug Administration
Published: 2025-11-07

Substantially Equivalent

Dreve Dentamid GmbH

FDA 510(k) clearance K250739 for Primeprint Direct Aligner, Substantially Equivalent on 2025-11-07. Applicant: Dreve Dentamid GmbH. Device class: 2.

Clearance details

Applicant: Dreve Dentamid GmbH
Product code: Code NXC
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 2025-03-11
Decision date: 2025-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Unna, DE

Download summary PDF View on FDA.gov ↗

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K253282 — ZSmile System2026-02-03
K251454 — Clear Aligner (SCF-3348)2026-01-07

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K162408 — Nano Varnish, Plaquit, Lightpaint on Surface2018-04-05
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Adverse events under product code NXC

product code NXC

Injury: 15,206
Malfunction: 2,576
Other: 9
Total: 17,791

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.