Cleared Traditional

PANA SPRAY Plus

K163483 · Nakanishi, Inc. · Dental
Aug 2017
Decision
246d
Days
Class 1
Risk

About This 510(k) Submission

K163483 is an FDA 510(k) clearance for the PANA SPRAY Plus, a Handpiece, Air-powered, Dental (Class I — General Controls, product code EFB), submitted by Nakanishi, Inc. (Kanuma-Shi, JP). The FDA issued a Cleared decision on August 15, 2017, 246 days after receiving the submission on December 12, 2016. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K163483 FDA.gov
FDA Decision Cleared SESE
Date Received December 12, 2016
Decision Date August 15, 2017
Days to Decision 246 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

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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