Cleared Traditional

High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L)

K233122 · Litu Tech , Ltd. · Dental
Apr 2024
Decision
216d
Days
Class 1
Risk

About This 510(k) Submission

K233122 is an FDA 510(k) clearance for the High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L), a Handpiece, Air-powered, Dental (Class I — General Controls, product code EFB), submitted by Litu Tech , Ltd. (Guangdong, CN). The FDA issued a Cleared decision on April 30, 2024, 216 days after receiving the submission on September 27, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K233122 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 2023
Decision Date April 30, 2024
Days to Decision 216 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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