Cleared Traditional

Luvis Chair (LC700C)

K233921 · Dentis Co., Ltd. · Dental
Sep 2024
Decision
268d
Days
Class 1
Risk

About This 510(k) Submission

K233921 is an FDA 510(k) clearance for the Luvis Chair (LC700C), a Chair, Dental, With Operative Unit (Class I — General Controls, product code KLC), submitted by Dentis Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on September 6, 2024, 268 days after receiving the submission on December 13, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.6250.

Submission Details

510(k) Number K233921 FDA.gov
FDA Decision Cleared SESE
Date Received December 13, 2023
Decision Date September 06, 2024
Days to Decision 268 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code KLC — Chair, Dental, With Operative Unit
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6250

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