Cleared Traditional

Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)

K240337 · Guangdong Jinme Medical Technology Co., Ltd. · Dental
Nov 2024
Decision
282d
Days
Class 1
Risk

About This 510(k) Submission

K240337 is an FDA 510(k) clearance for the Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L), a Handpiece, Air-powered, Dental (Class I — General Controls, product code EFB), submitted by Guangdong Jinme Medical Technology Co., Ltd. (Foshan, CN). The FDA issued a Cleared decision on November 13, 2024, 282 days after receiving the submission on February 5, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K240337 FDA.gov
FDA Decision Cleared SESE
Date Received February 05, 2024
Decision Date November 13, 2024
Days to Decision 282 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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