Cleared Traditional

K233921 - Luvis Chair (LC700C)

K233921 is an FDA 510(k) clearance for Luvis Chair (LC700C), manufactured by Dentis Co., Ltd.. The device is a Class 1 Dental device with product code KLC cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K233921 · Dentis Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2024
Decision
268d
Days
Class 1
Risk

K233921 is an FDA 510(k) clearance for the Luvis Chair (LC700C). Classified as Chair, Dental, With Operative Unit (product code KLC), Class I - General Controls.

Submitted by Dentis Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on September 6, 2024 after a review of 268 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6250 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Dentis Co., Ltd. devices

FDA 510(k) Submission Details - K233921

510(k) Number K233921 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
141d slower than avg
Panel avg: 127d · This submission: 268d
Pathway characteristics
Predicate-based equivalence.

KLC Device Classification - Class 1, General Controls

Product Code KLC Chair, Dental, With Operative Unit
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6250
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KLC Chair, Dental, With Operative Unit

All 28
Devices cleared under the same product code (KLC) and FDA review panel - the closest regulatory comparables to K233921.
DCI Edge Dental Chair with Operative Unit
K151987 · Dci · Jun 2016
OPTIMA PLUS E DENTAL CHAIR
K971063 · King Dental Corp. · Jun 1997
PROSTYLE COMPACT
K963209 · Planmeca Oy · Oct 1996
KAVO SYSTEMATICA 1060
K940950 · Kavo America · Dec 1994
A-DEC 1040 CHAIR
K925119 · A-Dec, Inc. · Jan 1994
A-DEC 2170 DUO UNIT CUSP
K925314 · A-Dec, Inc. · Dec 1993