Amalgamator, Dental, Ac-powered
Dental · 21 CFR 872.3100
Recent MDR events
6 adverse event reports on file
- VIALMIX®RFID DEFINITYJul 17, 2025MalfunctionLantheus Medical Imaging, Inc.22529697
- DENTAL AMALGAMMar 23, 2021InjuryUnkMW5100227
- 3M CAPMIXJun 21, 2018Injury3m Deutschland Gmbh9611385-2018-00004
- 3M ESPE PENTAMIX LITE AUTOMATIC MIXING UNITNov 11, 20143m Deutschland Gmbh9611385-2014-00016
- 3M ESPE PENTAMIX 3 AUTOMATIC MIXING UNITOct 31, 20143m Deutschland Gmbh9611385-2014-00014
- UNKJul 29, 2003InjuryUnkMW1029167
Event type breakdown
Most-reported manufacturers
Recalls
1 recall events for this product code
Registered firms
34 firms currently registered for this product code
Ivoclar Vivadent Manufacturing Gmbh
BURS Vorarlberg, AT
Gc Corp.
ITABASHI-KU Tokyo, JP
Dmg Chemisch Pharmazeutische Fabrik Gmbh
HAMBURG, DE
Renfert Gmbh
HILZINGEN Baden-Wurttemberg, DE
Voco Gmbh
CUXHAVEN Lower Saxony, DE
Gc America Inc.
ALSIP, IL, US
Solventum Germany Gmbh
SEEFELD Bavaria, DE
Tpc Advanced Technology, Inc.
City Industry, CA, US
Ivoclar Vivadent Gmbh
Ellwangen Baden-Wurttemberg, DE
Kerr Corporation
ORANGE, CA, US
Lakong Medical Devices Co., Ltd.
Dongguan Guangdong, CN
Ivoclar Vivadent, Inc.
Mississauga Ontario, CA
Huizhou Videya Technology Co., Ltd.
Huizhou Guangdong, CN
Dentsply Llc
York, PA, US
Shofu Inc.
FUKUINE, HIGASHIYAMA-KU Kyoto, JP
Motion Dental Equipment Corporation
New Taipei City, TW
Den-mat Holdings, Llc
Lompoc, CA, US
Dmg America Llc
ENGLEWOOD, NJ, US
Monitex Industrial Co., Ltd.
SAN-CHUNG CITY Taipei, TW
Foshan Coxo Medical Instrument Co., Ltd.
Foshan Guangdong, CN
3d Dental Desings And Development
Shaker Heights, OH, US
Chung Song Industrial Co.
YONGIN-SI Gyeonggi, KR
Lantheus Medical Imaging, Inc.
N Billerica, MA, US
Enercon Technologies
GRAY, ME, US
510(k) clearances
15 clearances for this product code
- Espe Dental AGJul 26, 1999
K991913 · PENTAMIX 2
- Ivoclar North America, Inc.Oct 6, 1992
K923974 · SILIMAT PLUS
- Ipt Technologies, Inc.Jun 3, 1992
K922203 · IPT CAPSULE MIXER
- Kerr Corporation (Danbury)Mar 2, 1992
K915847 · AUTOMIX DENTAL AMALGAMATOR
- Degussa AGNov 13, 1991
K914340 · DUOMAT 3 AMALGAMATOR
- Degussa AGNov 13, 1991
K914341 · MIXOMAT AMALGAMATOR
- Degussa AGNov 7, 1991
K914339 · DENTOMAT 3 AMALGAMATORS
- Wykle Research, Inc.Mar 15, 1991
K910632 · ACCU-MIX AMALGAMATOR