LUXATOR LX HANDPIECE— 510(k) K133178

Substantially Equivalent

Directa AB

FDA 510(k) clearance K133178 for LUXATOR LX HANDPIECE, Substantially Equivalent on 2015-11-24. Applicant: Directa AB.

Clearance details

Applicant: Directa AB
Product code: Code EGS
Advisory panel: Dental
Date received: 2013-10-17
Decision date: 2015-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Upplands Vasby, SE

Download summary PDF View on FDA.gov ↗

Adverse events under product code EGS

product code EGS

Injury: 356
Malfunction: 759
Total: 1,115

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.