K991701

Substantially Equivalent

MACH-SIGMA HANDPIECE, ULTRAPUSH, MODELS MACH-SIGMA MU (MINI HEAD), MACH-SIGMA SU (STD. HEAD), MACH-SIGMA TU (TORQUE HD)

Applicant: Nsk Nakanishi, Inc.
Product code: EFB
Advisory panel: Dental
Date received: 1999-05-19
Decision date: 1999-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tochigi-Ken, JP

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.