Cleared Traditional

Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip)

K241880 · Nakanishi, Inc. · Dental
Sep 2024
Decision
84d
Days
Class 1
Risk

About This 510(k) Submission

K241880 is an FDA 510(k) clearance for the Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip), a Handpiece, Air-powered, Dental (Class I — General Controls, product code EFB), submitted by Nakanishi, Inc. (Kanuma, JP). The FDA issued a Cleared decision on September 20, 2024, 84 days after receiving the submission on June 28, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K241880 FDA.gov
FDA Decision Cleared SESE
Date Received June 28, 2024
Decision Date September 20, 2024
Days to Decision 84 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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