MICR02 OSA DEVICE— 510(k) K133683

Substantially Equivalent

Microdental, Inc.

FDA 510(k) clearance K133683 for MICR02 OSA DEVICE, Substantially Equivalent on 2014-07-24. Applicant: Microdental, Inc..

Clearance details

Applicant: Microdental, Inc.
Product code: Code LRK
Advisory panel: Dental
Date received: 2013-12-02
Decision date: 2014-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dublin, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LRK

product code LRK

Injury: 246
Malfunction: 1,044
Total: 1,290

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.