Cleared Traditional

E-TYPE SPEED REDUCER CONTRA ANGLE

K970953 · Nsk Nakanishi, Inc. · Dental
Apr 1997
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K970953 is an FDA 510(k) clearance for the E-TYPE SPEED REDUCER CONTRA ANGLE, a Handpiece, Rotary Bone Cutting (Class II — Special Controls, product code KMW), submitted by Nsk Nakanishi, Inc. (Tochigi-Ken, JP). The FDA issued a Cleared decision on April 15, 1997, 29 days after receiving the submission on March 17, 1997. This device falls under the Dental review panel. Regulated under 21 CFR 872.4120.

Submission Details

510(k) Number K970953 FDA.gov
FDA Decision Cleared SESE
Date Received March 17, 1997
Decision Date April 15, 1997
Days to Decision 29 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code KMW — Handpiece, Rotary Bone Cutting
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4120

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