KLCClass I

Chair, Dental, With Operative Unit

Dental · 21 CFR 872.6250

MDR events42All time

Recalls7All time

Registered firms18Currently listed

510(k) clearances63All time

Recent MDR events

42 adverse event reports on file

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A-DEC PAC IJan 31, 2022
MalfunctionA-dec, Inc.13391967
POWER SUPPLYSep 23, 2015
InjuryA-dec, Inc.3015729-2015-00002
SPIRIT 1700 DENTAL CHAIRDec 19, 2014
MalfunctionPelton & Crane1017522-2014-00016
RECLINING DENTAL CHAIRDec 12, 2014
InjuryMW5039678
NUSTAR DENTAL CHAIRSep 3, 2013
MalfunctionMarus1017522-2013-00015
DENTAL EZ ACCS CHAIRApr 11, 2012
OtherDental EzMW5025103
SPIRIT 1500 DENTAL CHAIRDec 2, 2011
InjuryPelton & Crane1017522-2011-00047
CHAIRMAN CHAIROct 25, 2011
InjuryPelton & Crane1017522-2011-00041
NUSTAR HYDRAULIC CHAIR DC 1700Jun 2, 2011
MalfunctionDental Equipment, Llc (dba Newberg Mfg)3004517290-2011-00006
MAXSTAR DC1690 DENTAL CHAIRMar 3, 2011
MalfunctionDental Equipment Llc (dba Newberg Manufacturing)3004517290-2011-00002

Event type breakdown

Malfunction32

Injury8

Other2

Most-reported manufacturers

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Siemens Pelton & Crane15 Pelton & Crane4 A-dec, Inc.3 Adec2 Dental Equipment Llc (dba Newberg Manufacturing)2 Dental Equipment, Llc (dba Newberg Manufacturing)2 Dental Equipment, Llc (dba Newberg Mfg)2 Pelton & Crane, Llc2

Recalls

7 recall events for this product code

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Pelton & Crane Company
TerminatedApr 9, 2010
Pelton & Crane Spirit 3000 Dental Chair.
The Dental Chair lacks a valid Device History Record.
Z-1311-2010 · View FDA record ↗
Pelton & Crane Company
TerminatedApr 1, 2010
Pelton & Crane Dental Chairs, Chairman 5000 with magnetic headrest, Pelton & Crane, Charlotte, NC 28273.
Magnetic headrests may affect patients with implantable pacemakers and defibrillators.
Z-1179-2010 · View FDA record ↗
Pelton & Crane Company
TerminatedApr 1, 2010
Pelton & Crane Dental Chairs, Spirit 1500 with magnetic headrest, Pelton & Crane, Charlotte, NC 28273.
Magnetic headrests may affect patients with implantable pacemakers and defibrillators.
Z-1180-2010 · View FDA record ↗
Pelton & Crane Company
TerminatedApr 1, 2010
Pelton & Crane Dental Chairs, Spirit 1800 with magnetic headrest, Pelton & Crane, Charlotte, NC 28273.
Magnetic headrests may affect patients with implantable pacemakers and defibrillators.
Z-1324-2010 · View FDA record ↗
Pelton & Crane Company
TerminatedApr 1, 2010
Pelton & Crane Dental Chairs, Spirit 2000 with magnetic headrest, Pelton & Crane, Charlotte, NC 28273.
Magnetic headrests may affect patients with implantable pacemakers and defibrillators.
Z-1325-2010 · View FDA record ↗
Pelton & Crane Company
TerminatedApr 1, 2010
Pelton & Crane Dental Chairs, Spirit 3000 with magnetic headrest, Pelton & Crane, Charlotte, NC 28273.
Magnetic headrests may affect patients with implantable pacemakers and defibrillators.
Z-1326-2010 · View FDA record ↗
A-Dec Inc
TerminatedUnknown
A-dec Decade Plus 1221 Dental Chair
The design of the Decade Plus 1221 chair backrest creates a possible pinch-point between the chair backrest and the underside of the armrests.
Z-0541-2011 · View FDA record ↗

Registered firms

18 firms currently registered for this product code

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Mipont Medical Equipment Co., Ltd.
guangzhou Guangdong, CN
Osstem Implant Co.,ltd.
Yeonsu-gu Incheon, KR
Alliage S/a Industrias Medico Odontologica
Ribeirao Preto Sao Paulo, BR
Beyes Dental Inc
Toronto Ontario, CA
Osstem Implant Co., Ltd. Chair Business
Ansan-si Gyeonggi, KR
Jiangsu Dynamic Medical Technology Co., Ltd
Suzhou Jiangsu, CN
Foshan Gladent Medical Instrument Co.,ltd.
Foshan Guangdong, CN
Dentis Medical Division
Dong-gu Daegu, KR
Dci International, Llc
NEWBERG, OR, US
Ac Equipamentos Medicos E Odontologicos Ltda
Ribeirao Preto Sao Paulo, BR
Dentis Medical Division
Daegu, KR
Dds Dentalab
Ft Washington, PA, US
Osstem Implant Co., Ltd.
Gangseo-gu Seoul, KR
Summit Dental Systems Llc.
Fort Lauderdale, FL, US
Guangdong Yadeng Medical Apparatus Co.,ltd
Foshan Guangdong, CN

510(k) clearances

63 clearances for this product code

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Dentis Co., Ltd.Sep 6, 2024
K233921 · Luvis Chair (LC700C)
DciJun 1, 2016
K151987 · DCI Edge Dental Chair with Operative Unit
Shanghai Foshion Medical Instruments Co., Ltd.Dec 14, 2007
K071353 · FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C
King Dental Corp.Jun 3, 1997
K971063 · OPTIMA PLUS E DENTAL CHAIR; A DENTAL CHAIR; EXCEL CHAIR
Planmeca OyOct 24, 1996
K963209 · PROSTYLE COMPACT
Dentech Corp.Feb 27, 1995
K942870 · ULTIMA 2 DENTAL CHAIR
Kavo AmericaDec 29, 1994
K940950 · KAVO SYSTEMATICA 1060
Dentalez GroupMar 10, 1994
K925567 · E 4000 DENTAL OPERATING CHAIR