Cleared Traditional

PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.)

K990682 · Nsk Nakanishi, Inc. · Dental
Mar 1999
Decision
21d
Days
Class 1
Risk

About This 510(k) Submission

K990682 is an FDA 510(k) clearance for the PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.), a Handpiece, Direct Drive, Ac-powered (Class I — General Controls, product code EKX), submitted by Nsk Nakanishi, Inc. (Tochigi-Ken, JP). The FDA issued a Cleared decision on March 24, 1999, 21 days after receiving the submission on March 3, 1999. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K990682 FDA.gov
FDA Decision Cleared SESE
Date Received March 03, 1999
Decision Date March 24, 1999
Days to Decision 21 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EKX — Handpiece, Direct Drive, Ac-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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