CLEAR IMAGE ALIGNER— 510(k) K071970

Substantially Equivalent

Specialty Appliance Works, Inc.

FDA 510(k) clearance K071970 for CLEAR IMAGE ALIGNER, Substantially Equivalent on 2007-09-25. Applicant: Specialty Appliance Works, Inc..

Clearance details

Applicant: Specialty Appliance Works, Inc.
Product code: Code NXC
Advisory panel: Dental
Date received: 2007-07-17
Decision date: 2007-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marietta, GA, US

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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.