MACH-SIGMA HANDPIECE, ULTRAPUSH, MODELS MACH-SIGMA MU (MINI HEAD), MACH-SIGMA SU (STD. HEAD), MACH-SIGMA TU (TORQUE HD)— 510(k) K991701

Clearance details

Applicant

Nsk Nakanishi, Inc.

Product code

Code EFB

Device class

Class 1

Regulation

21 CFR 872.4200

Advisory panel

Dental

Date received

1999-05-19

Decision date

1999-08-10

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Tochigi-Ken, JP

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• K991021 — SONIC SCALER WITH FIBER OPTIC, MODEL NAS-L, SONIC SCALER WITHOUT FIBER OPTIC, MODEL NAS-NL1999-06-23
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• K990646 — PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE1999-03-19
• K980162 — MACH-SIGMA HANDPIECE, ULTRAPUSH1998-06-05

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 →