Wax, Dental, Intraoral
Dental · 21 CFR 872.6890
Recent MDR events
8 adverse event reports on file
- HYGENIC WAXJan 2, 2024InjuryColtene Whaledent Inc.2416455-2023-00001
- WALGREENS ORTHO WX 2PKSep 9, 2019MalfunctionRanir Llc1825660-2019-00612
- ORTHO WAXAug 14, 2017InjuryRanir Llc1825660-2017-00133
- BRACE GARDMay 12, 2010InjuryDentsply Raintree Essix Glenroe1036212-2010-00062
- PATIENT RELIEF WAXJan 15, 2010InjuryGlenroe Technologies1036212-2009-00205
- PT RELIEF WAXJul 21, 2009InjuryGlenroe Technologies1036212-2009-00084
- DENTAURUM WAXOct 26, 2007InjuryDentsply Glenroe1036212-2007-00190
- ELMEX WAXOct 11, 2007InjuryDentsply Glenroe1036212-2007-00165
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
208 firms currently registered for this product code
Medtech Products, Inc.
Tarrytown, NY, US
Huanghua Promisee Dental Co., Ltd
Huanghua Hebei, CN
3d Dental Desings And Development
Shaker Heights, OH, US
Yangzhou Yichuan Plastic Technology Co., Ltd.
Yangzhou City Jiangsu, CN
Merz Dental Gmbh
LUETJENBURG Schleswig-Holstein, DE
Gda Marketing Limited
KOWLOON, HK
Yangzhou Chenxiao Brush Industrial Co., Ltd.
YANGZHOU Jiangsu, CN
First Dental Supplies Llc
Winter Garden, FL, US
Smylio
Fremont, CA, US
Shandong Huge Dental Material Corporation
Rizhao Shandong, CN
Hangzhou Pengwu Medical Equipment Co.,ltd
Hangzhou Zhejiang, CN
Meta Dental Corp.
Glendale, NY, US
Xplora Usa Llc
Carrollton, TX, US
Gc Corp.
ITABASHI-KU Tokyo, JP
Maxill, Inc.
ST. THOMAS Ontario, CA
Unisource Shanghai Ltd.
SHANGHAI, CN
Jmu Dental, Inc
Fullerton, CA, US
Ortho Organizers, Inc.
Savannah, GA, US
Yangzhou Royal Home Products Manufacture Co., Ltd.
Yangzhou Jiangsu, CN
Ranir Llc
Grand Rapids, MI, US
Young Innovations Inc.
Algonquin, IL, US
Aid United International Co., Limited
SHANGHAI, CN
Shummi Enterprise Co., Ltd.
Taipei, TW
Battech
Irvine, CA, US
Prime Dental Manufacturing, Inc.
CHICAGO, IL, US
510(k) clearances
25 clearances for this product code
- Udent, Inc.Feb 11, 2002
K020009 · BRACE EZE
- Glenroe TechnologiesJan 27, 1995
K945535 · GLENROE ORTHO-SIL
- Heraeus Kulzer, Inc.Nov 17, 1992
K924024 · ORTHO WAX
- Dentsply Intl.Sep 29, 1992
K923586 · BURNOUT MATERIAL
- Orion Diagnostica, Inc.Sep 2, 1992
K914892 · SALIVA-STIM
- Dentsply Intl.Jun 16, 1992
K922380 · BITE RIM WAX
- Heraeus Kulzer, Inc.Mar 19, 1992
K914513 · PALAVIT G
- Pemaco, Inc.Aug 21, 1991
K910676 · INTRAORAL DENTAL WAX