Plugger, Root Canal, Endodontic
Dental · 21 CFR 872.4565
Recent MDR events
71 adverse event reports on file
- MACHTOU-PLUGGER 001/002May 11, 2023MalfunctionVdw Gmbh9611053-2023-00783
- PLUGGER 1-2Feb 9, 2023MalfunctionMaillefer Instruments Holding Sarl8031010-2023-00741
- HEAT-CARRIER PLUGGER 1-2Nov 8, 2022MalfunctionMaillefer Instruments Holding Sarl8031010-2022-00681
- HEAT-CARRIER PLUGGER 2-4Nov 8, 2022MalfunctionMaillefer Instruments Holding Sarl8031010-2022-00682
- HEAT-CARRIER PLUGGER 2-3Nov 8, 2022MalfunctionMaillefer Instruments Holding Sarl8031010-2022-00683
- GUTTA-PERCHA PLUGGERJan 8, 2020MalfunctionDentsply Maillefer8031010-2019-00287
- GUTTA-PERCHA PLUGGERAug 8, 2019MalfunctionDentsply Maillefer8031010-2019-00137
- MACHTOU PLUGGER 001/002Dec 6, 2018MalfunctionDentsply Vdw Gmbh9611053-2018-00221
- SYBRONENDOOct 23, 2018MalfunctionSybronendo2016150-2018-00044
- SYBRONENDOOct 23, 2018MalfunctionSybronendo2016150-2018-00056
Event type breakdown
Recalls
3 recall events for this product code
- Ormco/SybronendoTerminatedJun 14, 2013
SybronEndo Elements Obturation Unit; REF 973-0322; SN 91-1234; 2005-10; SybronEndo, 1332 S. Lone Hill Ave. Glendora, CA 91740; EU Rep: Kerr Italia, S.r.l, Via
A recall has been issued by SybronEndo because a Canadian Standards Association (CSA)-directed cautionary statement label was inadvertently omitted from the Elements Obturation Unit and its Replacement A/C Power Cord.
Z-1544-2013 · View FDA record ↗ - Ormco/SybronendoTerminatedJun 14, 2013
SybronEndo Replacement AC Power Cord, US Elements Obturation; REF 973-0334; SybronEndo, 1332 S. Lone Hill Ave. Glendora, CA 91740; EU Rep: Kerr Italia, S.r.l,
A recall has been issued by SybronEndo because a Canadian Standards Association (CSA)-directed cautionary statement label was inadvertently omitted from the Elements Obturation Unit and its Replacement A/C Power Cord.
Z-1545-2013 · View FDA record ↗ - Ormco/SybronendoTerminatedUnknown
Elements Obturation Unit (EOU) used with respective Buchanan Heat Pluggers
Buchanan Heat Pluggers will possibly overheat while used with the Elements Obturation Unit (EOU).
Z-0413-2018 · View FDA record ↗
Registered firms
148 firms currently registered for this product code
Cislak Manufacturing, Inc.
NILES, IL, US
Sds De Mexico S. De R.l. De C.v.
MEXICALI, B.C. C.P. Baja California, MX
Young Innovations Inc.
Algonquin, IL, US
Medcave Private Limited
Sialkot Punjab, PK
Osung Mnd Co., Ltd.
Gimpo-si Gyeonggi, KR
Shanghai Fanta Dental Materials Co., Ltd.
Shanghai, CN
Pomee Corporation
Sialkot Punjab, PK
Mani, Inc. (head Office)
UTSUNOMIYA Tochigi, JP
Denta Craft Instruments
Sialkot Punjab, PK
Enova Illumination, Inc
Minneapolis, MN, US
Devemed Gmbh
NEUHAUSEN OB ECK Baden-Wurttemberg, DE
Shenzhen Superline Technology Co.,ltd
Shenzhen Guangdong, CN
Avilign Medical
Sialkot Punjab, PK
Aesculap, Inc.
CENTER VALLEY, PA, US
Lacigrus International
Sialkot Punjab, PK
Dentimed Sao Joao
Sunrise, FL, US
Cdm Center Of Excellence Ltd.
Beijing, CN
Nusmile, Ltd
HOUSTON, TX, US
Nopa Instruments, Medizintechnik Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Gebr. Brasseler Gmbh & Co. Kg
LEMGO North Rhine-Westphalia, DE
United Dental Changzhou
Changzhou Jiangsu, CN
Nova Instruments
Berkshire Wokingham, GB
Kerr Italia, S.r.l.
SCAFATI Salerno, IT
Rz Medizintechnik Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Shanghai Smedent Medical Instrument Co., Ltd
Shanghai, CN
510(k) clearances
6 clearances for this product code
- B&L Biotech Co., Ltd.Jun 5, 2006
K060347 · B&L L-BETA, MODEL WL-B1
- Young O/S, LLCDec 1, 2004
K042828 · OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700
- Sybron Endo/AnalyticApr 28, 2004
K031664 · ELEMENTS OBTURATION UNIT
- Dentsply Intl.Mar 26, 1986
K860569 · ENDODONTIC ROOT CANAL PLUGGER
- Union BranchJul 12, 1983
K831748 · ENDODONTIC ROOT CANAL PLUGGER FINGER-
- Techdent, Inc.Aug 3, 1979
K791019 · MCSPADDEN CONDENSOR