VIGOR A LOW SPEED AIR MOTOR, VIGOR C LOW SPEED CONTRA-ANGLE HANDPIECES, VIGOR S LOW SPEED STRAIGHT HANDPIECES— 510(k) K112305

Substantially Equivalent

Thunder Tiger Corp.

FDA 510(k) clearance K112305 for VIGOR A LOW SPEED AIR MOTOR, VIGOR C LOW SPEED CONTRA-ANGLE HANDPIECES, VIGOR S LOW SPEED STRAIGHT HANDPIECES, Substantially Equivalent on 2012-04-17. Applicant: Thunder Tiger Corp..

Clearance details

Applicant: Thunder Tiger Corp.
Product code: Code EGS
Advisory panel: Dental
Date received: 2011-08-11
Decision date: 2012-04-17
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Taichung, TW

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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.