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510(k) K233921

Device
Luvis Chair (LC700C)
Applicant
Dentis Co., Ltd.
510(k) number
K233921
Product code
KLC
Decision
Substantially Equivalent (SESE)
Decision date
2024-09-06
Date received
2023-12-13
Regulation
872.6250
Classification name
Chair, Dental, With Operative Unit
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Kim Kaon
Address
99, Seongseoseo-Ro Dalseo-Gu Daegu KR 42718 42718

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KLC#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K151987DCI Edge Dental Chair with Operative UnitDci2016-06-01
K071353FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48CShanghai Foshion Medical Instruments Co., Ltd.2007-12-14
K971063OPTIMA PLUS E DENTAL CHAIR; A DENTAL CHAIR; EXCEL CHAIRKing Dental Corp.1997-06-03
K963209PROSTYLE COMPACTPlanmeca Oy1996-10-24
K942870ULTIMA 2 DENTAL CHAIRDentech Corp.1995-02-27
K940950KAVO SYSTEMATICA 1060Kavo America1994-12-29
K925567E 4000 DENTAL OPERATING CHAIRDentalez Group1994-03-10
K923534PM2002 PROLINEPlanmeca USA, Inc.1994-01-31
K925119A-DEC 1040 CHAIRA-Dec, Inc.1994-01-31
K925319A-DEC 2182 DOCTOR'S UNITA-Dec, Inc.1993-12-09
K925314A-DEC 2170 DUO UNIT CUSPA-Dec, Inc.1993-12-09
K925315A-DEC 2171 DUO UNITA-Dec, Inc.1993-12-09
K925316A-DEC 2172 DOCTOR'S UNITA-Dec, Inc.1993-12-09
K925317A-DEC 2180 DUO UNIT, CUSPA-Dec, Inc.1993-12-09
K925318A-DEC 2181 DUO UNITA-Dec, Inc.1993-12-09