DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 100, 101, 200, 201 AND 202— 510(k) K052822

Substantially Equivalent

Thunder Tiger Corp.

FDA 510(k) clearance K052822 for DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 100, 101, 200, 201 AND 202, Substantially Equivalent on 2006-01-20. Applicant: Thunder Tiger Corp..

Clearance details

Applicant: Thunder Tiger Corp.
Product code: Code EFB
Advisory panel: Dental
Date received: 2005-10-04
Decision date: 2006-01-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsin Chu City, TW

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Adverse events under product code EFB

product code EFB

Injury: 133
Malfunction: 562
Total: 695

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.