Argen Clear Aligner, Argen Clear Aligner Premium— 510(k) K192846

Name: FDA 510(k) clearance K192846
Creator: U.S. Food and Drug Administration
Published: 2020-02-10

Substantially Equivalent

Argen Corporation

FDA 510(k) clearance K192846 for Argen Clear Aligner, Argen Clear Aligner Premium, Substantially Equivalent on 2020-02-10. Applicant: Argen Corporation. Device class: 2.

Clearance details

Applicant: Argen Corporation
Product code: Code NXC
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 2019-10-03
Decision date: 2020-02-10
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

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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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.