Light, Fiber Optic, Dental
Dental · 21 CFR 872.4620
Recent MDR events
4 adverse event reports on file
- ISOLITE SYSTEM MOUTHPIECEOct 16, 2013InjuryInnerlite, Inc., Dba Isolite Systems2032574-2013-00001
- QHL75CURING LIGHTMay 14, 2001MalfunctionL.d. Caulk2515379-2001-00004
- ELIPAR HIGHLIGHTJul 8, 1998MalfunctionEspe Dental-medizin Gmbh & Co.kg.9611385-1998-00004
- COLTOLUX CURING LIGHTFeb 14, 1997MalfunctionColtene/whaldent Inc.2416455-1997-00001
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
25 firms currently registered for this product code
Dhef Inc.
NEW TAIPEI CITY, TW
Zimmer, Inc.
WARSAW, IN, US
Kerr Corporation
Pomona, CA, US
Dentamerica
City of Industry, CA, US
Dongguan Wanjin Industrial Co., Ltd
DongGuang Guangdong, CN
Salvin Dental Specialties, Llc
CHARLOTTE, NC, US
Lakong Medical Devices Co., Ltd.
Dongguan Guangdong, CN
Endonest Medical Systems Llp
PALGHAR Maharashtra, IN
Dentech Corp.
TOKYO, JP
Quality Aspirators, Inc.
Dallas, TX, US
Tpc Advanced Technology, Inc.
City Industry, CA, US
Invidia Medical Gmbh U Co Kg
Emmingen-Liptingen Baden-Wurttemberg, DE
Denbur, Inc.
WESTMONT, IL, US
Dent Zar, Inc.
Canoga Park, CA, US
Sds De Mexico S. De R.l. De C.v.
MEXICALI, B.C. C.P. Baja California, MX
Apoza Enterprise Co., Ltd.
Hsin-Chuang District New Taipei, TW
Reliance Orthodontic Products, Inc.
ITASCA, IL, US
Kmi Imi Group / Dba: Innovative Med, Inc.
IRVINE, CA, US
Quality Aspirators, Inc.
Duncanville, TX, US
H & H Co.
Hayden, ID, US
Hager Worldwide, Inc.
Hickory, NC, US
Dentimed Sao Joao
Sunrise, FL, US
Alira Medical Devices Llc
Rancho Cucamonga, CA, US
Micro Diamond Technologies Ltd.- Medicnrg Ltd.
AFULA Northern, IL
Dntlworks Equipment Corp.
Centennial, CO, US
510(k) clearances
18 clearances for this product code
- Beaverstate Dental, Inc.Sep 5, 1995
K953191 · MODEL A15-101
- Beaverstate Dental, Inc.Sep 5, 1995
K953192 · MODEL A15-103
- Jedental Co., Inc.Jan 26, 1994
K935718 · JEDENTAL VLC DENTAL CURING LIGHT
- Stryker Corp.Aug 3, 1987
K871816 · STRYKERSCOPE TM/ORTHOSCOPE TM/STRYKER MINISCOPE TM
- Ritter Co.Aug 12, 1983
K831976 · POWER OPTIC
- Silverman'SAug 11, 1983
K831824 · DENTAL ELECTRONIC/S.B.R TRADING BU HAND
- Chayes Virginia, Inc.May 5, 1982
K820907 · DENTISCOPE
- Venture Technology, Inc.Oct 2, 1981
K812605 · FIBER OPTIC LIGHT SOURCE I