Syringe, Restorative And Impression Material
Dental · 21 CFR 872.4565
Recent MDR events
9 adverse event reports on file
- MIXING TIPS DS-50. MEDIUM SHORT PINK, 5.4 MMDec 26, 2023MalfunctionUnkMW5149598
- VIVAPEN SNAP-ON CANNULAS REFILLNov 18, 2022MalfunctionIvoclar Vivadent Ag9612352-2022-00002
- VIVAPEN SNAP-ON CANNULAS REFILLNov 14, 2022MalfunctionIvoclar Vivadent Ag9612352-2022-00001
- ASPIRATING SYRINGE TYPE ANov 2, 2012InjuryIntegra York, Pa Inc2523190-2012-00091
- EXTRUDE WASHNov 2, 2011InjuryKerr Corporation1815757-2011-00004
- EXTRUDE WASHNov 1, 2011InjuryKerr Corporation1815757-2011-00003
- UNKNOWN ESTHET-XFeb 4, 2011InjuryDentsply Caulk2515379-2011-00001
- EXTRUDER GUNSep 8, 2008InjuryKerr Corporation1815757-2008-00005
- COMPULE SYRINGE (COMPULES TIPS GUN)Nov 26, 2002MalfunctionDentsply Caulk2515379-2002-00055
Event type breakdown
Most-reported manufacturers
Recalls
1 recall events for this product code
Registered firms
173 firms currently registered for this product code
Sts Corporation
Duluth, GA, US
Ivoclar Vivadent Ag
SCHAAN, LI
Kulzer Gmbh
HANAU Hesse, DE
Huanghua Promisee Dental Co., Ltd
Huanghua Hebei, CN
Anqing Clean Dental Instrument Technology Co.,ltd
Anqing City Anhui, CN
Voco Gmbh
CUXHAVEN Lower Saxony, DE
Kuraray Noritake Dental Niigata Plant
TAINAI Niigata, JP
Hefei Mlush Sanitary Products Co.,ltd
Hefei Anhui, CN
Gc America Inc.
ALSIP, IL, US
Dreve Dentamid Gmbh
UNNA North Rhine-Westphalia, DE
Pac-dent Inc.
Brea, CA, US
Shenzhen Denco Medical Co., Ltd.
Shenzhen Guangdong, CN
Dxm Co., Ltd.
Hwasun-gun Jeonnam, KR
Scientific Pharmaceuticals, Inc.
POMONA, CA, US
Helmut Zepf Medizintechnik Gmbh
SEITINGEN Baden-Wurttemberg, DE
Bgss Company Asia Limited
Zhabei Shanghai, CN
Xiantao S&j Protective Products Co., Ltd
Xiantao Hubei, CN
Battech
Irvine, CA, US
Dentimed Sao Joao
Sunrise, FL, US
Atomo Dental, Inc.
Pleasanton, CA, US
Zhermack S.p.a.
BADIA POLESINE (RO) Rovigo, IT
Young Microbrush Llc
GRAFTON, WI, US
The Belport Company, Inc Dba Gingi-pak
CAMARILLO, CA, US
Lacigrus International
Sialkot Punjab, PK
Prismatik Dentalcraft, Inc.
Irvine, CA, US
510(k) clearances
13 clearances for this product code
- Bio-Interfaces, Inc.Jul 12, 1994
K941431 · BONE GRAFT DELIVERY SYRINGES
- Centrix, Inc.Feb 25, 1992
K913974 · ACCESS IMPRESSION BARREL
- Dentsply Intl.Sep 16, 1987
K873153 · CAULK'S VPS CARTRIDGE SYSTEM
- Dentsply Intl.Jun 5, 1987
K871937 · IMPRESSION SYRINGE
- Coltene, Inc.Oct 30, 1986
K863998 · COLTENE JET-MIXER
- Centrix, Inc.Aug 23, 1985
K853282 · CENTRIX RIBBON TUBES
- Unitek Corp.Apr 29, 1985
K851386 · UNITEK DISPOSABLE IMPRESSION SYRINGE
- G-C Intl. Corp.Oct 6, 1981
K812680 · G-C IMPRESSION SYRINGE