High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L)— 510(k) K233122

Substantially Equivalent

Litu Tech , Ltd.

FDA 510(k) clearance K233122 for High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L), Substantially Equivalent on 2024-04-30. Applicant: Litu Tech , Ltd..

Clearance details

Applicant: Litu Tech , Ltd.
Product code: Code EFB
Advisory panel: Dental
Date received: 2023-09-27
Decision date: 2024-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangdong, CN

Download summary PDF View on FDA.gov ↗

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.