Cleared Traditional

Surgical Angle Handpiece, Surgical Straight Handpiece

K171155 · Nakanishi, Inc. · Dental
Nov 2017
Decision
215d
Days
Class 2
Risk

About This 510(k) Submission

K171155 is an FDA 510(k) clearance for the Surgical Angle Handpiece, Surgical Straight Handpiece, a Handpiece, Rotary Bone Cutting (Class II — Special Controls, product code KMW), submitted by Nakanishi, Inc. (Kanuma-Shi, JP). The FDA issued a Cleared decision on November 21, 2017, 215 days after receiving the submission on April 20, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.4120.

Submission Details

510(k) Number K171155 FDA.gov
FDA Decision Cleared SESE
Date Received April 20, 2017
Decision Date November 21, 2017
Days to Decision 215 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

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