Material, Impression Tray, Resin
Dental · 21 CFR 872.3670
Recent MDR events
8 adverse event reports on file
- 3M ESPE POLYETHER ADHESIVEAug 7, 2013Injury3m Deutschland Gmbh9611385-2013-00013
- POLYETHER ADHESIVEMar 15, 2010Injury3m Espe Ag9611385-2010-00004
- FIX TRAY ADHESIVEAug 3, 2007InjuryDentsply Detrey-dedent8010638-2007-00139
- HYDROSILJan 20, 2006Injury*2515379-2005-00540
- JELTRATEApr 22, 2005InjuryDentsply Caulk2515379-2005-00106
- AQUASIL ULTRAMar 17, 2005InjuryDentsply Caulk2515379-2005-00070
- NEO-PLX RB TRAYJan 15, 1999OtherHeraeus Kulzer, Inc.1925223-1998-00001
- PERMADYNE PENTA LDec 22, 1998InjuryEspe Dental Ag9611385-1998-00010
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
197 firms currently registered for this product code
Solventum Orthodontics Corporation
Monrovia, CA, US
Richbolt Enterprises
SIALKOT Punjab, PK
Dmg Digital Enterprises Se
Hamburg, DE
Guangzhou Heygears Imc.inc
Guangzhou Guangdong, CN
Formlabs Ohio, Inc.
Millbury, OH, US
Dentsply Sirona Inc
York, PA, US
Changzhou Ou Nuo Medical Equipment Co., Ltd.
Changzhou City Jiangsu, CN
Keystone Industries
CHERRY HILL, NJ, US
Smd Dental Laboratory
Heungdeok-gu Cheongju-si Chungbuk, KR
Guilin Kevin Peter Technology Co., Ltd.
Guilin Guangxi, CN
Solventum Germany Gmbh
Kamen North Rhine-Westphalia, DE
The Argen Corporation
San Diego, CA, US
Keystone Industries
Myerstown, PA, US
Anqing Clean Dental Instrument Technology Co.,ltd
Anqing City Anhui, CN
Philips Oral Healthcare, Llc
Bothell, WA, US
Kash Sales Inc.
Richmond Hill Ontario, CA
Ray America Inc
Fort Lee, NJ, US
Fricke Dental Mfg. Co.
Streamwood, IL, US
Prime Dental Manufacturing, Inc.
CHICAGO, IL, US
Xiamen Zhiyuan Medical Technology Co., Ltd.
XIAMEN Fujian, CN
Pulpdent Corporation
Watertown, MA, US
Merz Dental Gmbh
LUETJENBURG Schleswig-Holstein, DE
Improve Co.,limited
Hong Kong Xinjiang, CN
Scientific Pharmaceuticals, Inc.
POMONA, CA, US
Spident Co., Ltd.
INCHEON Gyeonggi, KR
510(k) clearances
30 clearances for this product code
- Bio-Systems ResearchJan 26, 1994
K933745 · PERMAGEN UNIVERSAL BONDING RESIN
- Heraeus Kulzer, Inc.Jun 18, 1993
K930487 · PALATRAY LC MINT
- Dentsply Intl.Nov 17, 1992
K923979 · LC TRAY MATERIAL
- Heraeus Kulzer, Inc.Sep 29, 1992
K923549 · PALADISC LC
- E&D Dental Products, Inc.Aug 21, 1991
K912820 · POLYESTER RESIN HAND MOLDED TRAY
- Kulzer, Inc.Jun 6, 1991
K905058 · PALAVIT L
- Kulzer, Inc.Jul 26, 1990
K902350 · PALATRAY LC RESIN IMPRESSION TRAY MATERIAL
- Productivity Training Corp.Jun 29, 1990
K901782 · CONVERTRAY CUSTOM IMPRESSION TRAY MATERIAL SYSTEM