Cleared Traditional

TI-MAX Z45

K121901 · Nakanishi, Inc. · Dental
Feb 2013
Decision
244d
Days
Class 1
Risk

About This 510(k) Submission

K121901 is an FDA 510(k) clearance for the TI-MAX Z45, a Handpiece, Contra- And Right-angle Attachment, Dental (Class I — General Controls, product code EGS), submitted by Nakanishi, Inc. (Bunkyo-Ku, JP). The FDA issued a Cleared decision on February 28, 2013, 244 days after receiving the submission on June 29, 2012. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K121901 FDA.gov
FDA Decision Cleared SESE
Date Received June 29, 2012
Decision Date February 28, 2013
Days to Decision 244 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EGS — Handpiece, Contra- And Right-angle Attachment, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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