Cleared Traditional

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

K991701 · Nsk Nakanishi, Inc. · Dental
Aug 1999
Decision
83d
Days
Class 1
Risk

About This 510(k) Submission

K991701 is an FDA 510(k) clearance for the MACH-SIGMA HANDPIECE, ULTRAPUSH, MODELS MACH-SIGMA MU (MINI HEAD), MACH-SIGMA SU (STD. HEAD), MACH-SIGMA TU (TORQUE HD), a Handpiece, Air-powered, Dental (Class I — General Controls, product code EFB), submitted by Nsk Nakanishi, Inc. (Tochigi-Ken, JP). The FDA issued a Cleared decision on August 10, 1999, 83 days after receiving the submission on May 19, 1999. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K991701 FDA.gov
FDA Decision Cleared SESE
Date Received May 19, 1999
Decision Date August 10, 1999
Days to Decision 83 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EFB — Handpiece, Air-powered, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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