DeviceClearance

U-Aligner— 510(k) K191308

Substantially Equivalent

Universal Orthodontic Laboratory, Inc.

FDA 510(k) clearance K191308 for U-Aligner, Substantially Equivalent on 2020-04-23. Applicant: Universal Orthodontic Laboratory, Inc.. Device class: 2.

Clearance details

Applicant
Universal Orthodontic Laboratory, Inc.
Product code
Code NXC
Device class
Class 2
Regulation
21 CFR 872.5470
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Norwalk, CA, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code NXC

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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, through . 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.