MTM(R) CLEAR ALIGNER— 510(k) K132145

Substantially Equivalent

Dentsply International, Inc.

FDA 510(k) clearance K132145 for MTM(R) CLEAR ALIGNER, Substantially Equivalent on 2013-10-11. Applicant: Dentsply International, Inc..

Clearance details

Applicant: Dentsply International, Inc.
Product code: Code NXC
Advisory panel: Dental
Date received: 2013-07-11
Decision date: 2013-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: York, PA, 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.