Cleared Traditional

Medidenta High Speed Handpieces

K202674 · Pac-Dent, Inc. · Dental
Dec 2022
Decision
818d
Days
Class 1
Risk

About This 510(k) Submission

K202674 is an FDA 510(k) clearance for the Medidenta High Speed Handpieces, a Handpiece, Air-powered, Dental (Class I — General Controls, product code EFB), submitted by Pac-Dent, Inc. (Brea, US). The FDA issued a Cleared decision on December 12, 2022, 818 days after receiving the submission on September 15, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K202674 FDA.gov
FDA Decision Cleared SESE
Date Received September 15, 2020
Decision Date December 12, 2022
Days to Decision 818 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

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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