Unit, Electrosurgical, And Accessories, Dental
Dental · 21 CFR 872.4920
Recent MDR events
13 adverse event reports on file
- SYBRONENDODec 26, 2018MalfunctionSybronendo2016150-2018-00064
- SYBRONENDODec 20, 2018MalfunctionSybronendo2016150-2018-00063
- SYBRONENDODec 19, 2018MalfunctionSybronendo2016150-2018-00062
- SYBRONENDOAug 24, 2018MalfunctionSybronendo2016150-2018-00051
- SENSIMATICJul 27, 2018InjuryParkell, Inc.2411797-2018-00001
- SYBRONENDOMay 24, 2018MalfunctionSybronendo2016150-2018-00019
- DENTO-SURG 90 F.F.P.F EMCMar 26, 2014OtherEllman International2428235-2014-00001
- ART-E1 ELECTROSURGERY UNITJul 27, 2009OtherBonart Co. Ltd.9710363-2009-00001
- DENTO-SURGEMar 26, 2004InjuryEllman International Inc.MW1031685
- DENTO-SURG 90 FFPJul 17, 2000InjuryEllman International Inc.2428235-2000-00004
Event type breakdown
Recalls
1 recall events for this product code
Registered firms
10 firms currently registered for this product code
Cynosure, Llc
Westford, MA, US
Parkell, Inc.
EDGEWOOD, NY, US
Satelec-acteon Group
MERIGNAC Gironde, FR
Macan Genesis Manufacturing Llc
Elmwood, WI, US
Blue Line Sterilization Services
Novato, CA, US
Coltene/whaledent Inc.
CUYAHOGA FALLS, OH, US
Bonart Co. Ltd.
KEELUNG, TW
J. Morita Mfg. Corp.
FUSHIMI-KU Kyoto, JP
Oketz Logistics Llc
Coral Gables, FL, US
510(k) clearances
19 clearances for this product code
- J. Morita USA, Inc.Aug 3, 2022
K213477 · Root ZX3
- Coltene/Whaledent, Inc.Oct 18, 2007
K071632 · PERFECT TISSUE CONTOURING SYSTEM II
- Medisurg , Ltd.Apr 18, 2007
K063468 · THE FUGO BLADE FOR DENTISTRY
- Macan Engineering Co.Dec 9, 2005
K052622 · MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT
- Macan Engineering Co.May 23, 2005
K050735 · MC6A
- Xo Care A/SApr 29, 2003
K023672 · X O ODONTOSURGE 4
- Diagnostic Data, Inc.Feb 19, 2002
K020080 · BONART ART-E1 ELECTROSURGERY UNIT
- Odonto-WaveAug 24, 2000
K001560 · ODONTOSURGE 3