FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K032099 |
(EMS SA) ELECTRO MEDICAL SYSTEMS |
SWISS MASTER LIGHT |
10/27/2003 |
K972355 |
3M COMPANY |
3M AURORA SYSTEM |
08/29/1997 |
K061395 |
ADDENT, INC. |
CALSET COMPOSITE HEATER |
06/23/2006 |
K982615 |
AIR TECHNIQUES, INC. |
AIRDENT RADIANCE CURING LIGHT |
08/24/1998 |
K070373 |
APOZA ENTERPRISE CO. LTD. |
APOZA LED CURING LIGHT, MODEL E-MORLIT, D-2000, TOP 3W, TOP 5W |
03/02/2007 |
K033201 |
APOZA ENTERPRISE CO. LTD. |
LA500 BLUE LIGHT |
12/02/2003 |
K040618 |
APOZA ENTERPRISE CO. LTD. |
LED TURBO |
03/25/2004 |
K041303 |
APOZA ENTERPRISE CO. LTD. |
LED TURBO-PEN |
06/18/2004 |
K970506 |
BENLIOGLU DENTAL ITHALAT INC. |
HILUX 200,250,275,300,350,500 DENTAL CURING LIGHT |
06/04/1997 |
K052122 |
BISCO, INC. |
BISCO LED |
03/29/2006 |
K000426 |
BISCO, INC. |
VIP- VARIABLE INTENSITY POLYMERIZER |
04/12/2000 |
K023721 |
BONART CO. LTD. |
BONART ART-L2 LIGHT CURING UNIT |
01/10/2003 |
K062289 |
BONART CO. LTD. |
BONART ART-L3 LED CURING LIGHT |
01/03/2007 |
K082971 |
BONART CO. LTD. |
BONART ART-L5 LED CORDLESS CURING LIGHT |
11/13/2008 |
K150585 |
CAO GROUP, INC. |
Ascent 3D |
12/31/2015 |
K020057 |
CAO GROUP, INC. |
PALMLIGHT |
08/27/2002 |
K061341 |
CAO GROUP, INC. |
PALMLIGHT 10, MODEL 001-00030 |
06/12/2006 |
K010133 |
CENTRIX, INC. |
VERSALUX |
04/05/2001 |
K221152 |
Changzhou Sifary Medical Technology Co., Ltd. |
CuringPen Dental Curing Light |
11/23/2022 |
K040551 |
COLTENE/WHALEDENT INC. |
COLTOLUX LED CURING LIGHT |
03/15/2004 |
K955763 |
DEMETRON RESEARCH CORP. |
OPTILUX 400 |
01/04/1996 |
K081287 |
DEN-MAT HOLDINGS, LLC |
SAPPHIRE PLASMA ARC DENTAL CURING LIGHT |
11/21/2008 |
K042196 |
DENFOTEX LIGHT SYSTEMS LTD |
SAVEDENT BLUE |
11/01/2004 |
K063659 |
DENT CORP. RESEARCH & DEVELOPMENT |
EASY CURING PEN-STYLE LED CURING LIGHT |
04/30/2007 |
K072807 |
DENT'N CO |
I LIGHT |
11/21/2007 |
K223142 |
Dent4You AG |
Coltolux Comfort LED Curing Light |
12/22/2022 |
K033697 |
DENTAL PRODUCTS OF USA, INC. |
POWER LED |
02/27/2004 |
K002925 |
DENTAL SYSTEMS.COM, INC. |
COOLBLU CURING LIGHT |
12/20/2000 |
K020171 |
DENTAL SYSTEMS.COM, INC. |
COOLBLU2 DENTAL RESIN CURING DEVICE |
01/29/2002 |
K170529 |
DENTALL Co., Ltd. |
Delight, Delight ortho, B&Lite S |
08/08/2017 |
K061658 |
DENTALL CORP. |
SPIRIT, MODEL M, U; DOCPORTMACRO, MODEL M, U, L |
09/18/2006 |
K140432 |
DENTALL CORPORATION |
HI-LIGHT, HI-LIGHT PLUS |
08/03/2015 |
K955759 |
DENTAMERICA |
LITEX 680 |
01/02/1996 |
K030641 |
DENTAURUM |
CONTEC LIGHT |
06/10/2003 |
K052593 |
DENTLIGHT INC. |
FUSION CURING LIGHT |
09/28/2005 |
K180065 |
DentLight Inc. |
FUSION Plus Curing Light |
04/19/2019 |
K221194 |
Dentmate Technology Co. Ltd. |
LEDEX |
09/16/2022 |
K131042 |
DENTMATE TECHNOLOGY CO., LTD. |
LEDEX |
10/03/2013 |
K163605 |
DENTMATE TECHNOLOGY CO., LTD. |
LEDEX WL070+ |
01/19/2017 |
K082408 |
DENTMATE TECHNOLOGY CO., LTD. |
LEDEX, MODEL: WL-070 |
12/03/2008 |
K031615 |
DENTSPLY INTERNATIONAL |
SLED CURING LIGHT SYSTEM |
07/21/2003 |
K041372 |
DENTSPLY INTERNATIONAL |
SMARTLITE PS PEN-STYLE LED CURING LIGHT |
06/24/2004 |
K191865 |
Dentsply Sirona |
SmartLite Pro Modular LED Curing Light |
11/20/2019 |
K043530 |
DESIGNS FOR VISION, INC. |
DVI CURING LIGHT |
01/25/2005 |
K130163 |
DIADENT GROUP INTERNATIONAL |
D-LUX |
08/16/2013 |
K200809 |
Diadent Group International |
D-LUX+ |
08/07/2020 |
K023748 |
DISCUS DENTAL, INC. |
FLASH-LITE II LED DENTAL CURING LIGHT |
01/17/2003 |
K022184 |
DISCUS DENTAL, INC. |
FLASH-LITE LED DENTAL CURING LIGHT |
08/20/2002 |
K073518 |
DISCUS DENTAL, INC. |
FLASHLITE REBEL* |
12/20/2007 |
K051571 |
DMETEC CO., LTD. |
SKYLIGHT LED CURING LIGHT |
07/19/2005 |
K173876 |
DXM Co., Ltd |
Cybird LED Curing Light |
01/24/2018 |
K191221 |
DXM Co., Ltd |
Cybird LED Curing Light |
01/10/2020 |
K042703 |
DXM CO., LTD. |
CYBIRD LED CURING LIGHT |
10/12/2004 |
K121093 |
DXM CO., LTD. |
D1 LED CURING LIGHT, SPEC 3, DENTRONIX LED 3000 |
11/27/2012 |
K071722 |
E.M.S. ELECTRO MEDICAL SYSTEMS S.A. |
DEEP BLUE |
08/10/2007 |
K033795 |
EELE LABORATORIES, LLC |
PLASMACURE BXE |
12/19/2003 |
K140281 |
EPIC MEDICAL CONCEPTS & INNOVATIONS |
FLEXI-LUME LED SYSTEM |
07/24/2014 |
K011154 |
ESPE DENTAL AG |
ELIPAR FREELIGHT |
05/16/2001 |
K984247 |
ESPE DENTAL AG |
ELIPAR TRILIGHT |
02/25/1999 |
K192009 |
EZGO Group Inc. |
LED Curing Light |
01/09/2020 |
K040956 |
FIRST MEDICAL INFECTION CONTROL ASSOCIATES, INC. |
HILUX LEDMAX 3 |
06/14/2004 |
K192233 |
Foshan CICADA Dental Instrument Co., Ltd. |
LED Curing Light |
02/13/2020 |
K220826 |
Foshan COXO Medical Instrument Co., Ltd. |
LED Curing Light |
12/08/2022 |
K200775 |
Garrison Dental Solutions, LLC |
LOOP LED Curing Light System |
08/14/2020 |
K050059 |
GC AMERICA, INC. |
G-LIGHT |
02/03/2005 |
K012134 |
GC AMERICA, INC. |
GC E-LIGHT |
08/07/2001 |
K093751 |
GOOD DOCTORS CO., LTD. |
CL-DC20, CL-DC21 |
02/24/2010 |
K223507 |
Good Doctors Co., Ltd. |
CL-DP40 (DrÆs Light PRIME), CL-DP40 (DrÆs Light CHOICE) |
08/04/2023 |
K071908 |
GOOD DOCTORS CO., LTD. |
DOCTOR'S LIGHT LED DENTAL CURING LIGHT |
08/23/2007 |
K173157 |
Good Doctors Co.,Ltd. |
Dr's Light2 |
05/29/2018 |
K994048 |
GREGORY S. JACOB, D.D.S. |
PORTABLE LIGHT CURING UNIT |
01/13/2000 |
K080025 |
GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD |
LED.L, LED.M, LED.G, LED.B |
03/19/2008 |
K042199 |
HERAEUS KULZER GMBH |
TRANSLUX POWER BLUE |
09/08/2004 |
K012341 |
HERAEUS KULZER, INC. |
TRANSLUX ENERGY |
08/30/2001 |
K992357 |
ICS OF NORTH AMERICA, INC. |
EASY-CURE (CURING AND WHITENING LIGHT) |
08/30/1999 |
K170101 |
Inter-Med / Vista Dental Products |
Valiant Curing Light |
06/08/2017 |
K972006 |
INTERACTIVE CONSULTING, INC. |
ACTA OEM MODULE |
07/10/1997 |
K062735 |
INVISIBLE TECHNOLOGY CO., LTD. |
TUTU 7, MODEL IV-T22 |
10/27/2006 |
K953898 |
ION LASER TECHNOLOGY |
ACL-5500 PRECISION CURING UNIT (PCU) |
02/15/1996 |
K974369 |
ION LASER TECHNOLOGY |
APOLLO 9500 |
01/06/1998 |
K964524 |
ION LASER TECHNOLOGY |
ILT ARGON HP |
03/18/1997 |
K190272 |
Ivoclar Vivadent, AG |
Bluephase PowerCure |
07/03/2019 |
K163613 |
IVOCLAR VIVADENT, AG |
Bluephase Style 20i |
04/04/2017 |
K013275 |
IVOCLAR VIVADENT, INC. |
ASTRALIS 10, MODELS # 559588, 561859 |
10/19/2001 |
K013277 |
IVOCLAR VIVADENT, INC. |
ASTRALIS 7, MODEL 557545 |
10/22/2001 |
K033520 |
IVOCLAR VIVADENT, INC. |
BLUEPHASE |
12/05/2003 |
K051782 |
IVOCLAR VIVADENT, INC. |
BLUEPHASE 16I |
09/20/2005 |
K091020 |
IVOCLAR VIVADENT, INC. |
BLUEPHASE 20I |
06/12/2009 |
K110756 |
IVOCLAR VIVADENT, INC. |
BLUEPHASE STYLE |
08/29/2011 |
K963110 |
J. MORITA USA, INC. |
JETLITE |
10/24/1996 |
K000078 |
J. MORITA USA, INC. |
JETLITE 4000 |
05/15/2000 |
K051780 |
J. MORITA USA, INC. |
JETLITE 5000 |
07/28/2005 |
K063529 |
J. MORITA USA, INC. |
PENCURE, MODEL VL-7 |
01/05/2007 |
K040614 |
J.L. BLOSSER, INC. |
BLUEWAND LED DENTAL CURING WAND SYSTEM |
04/07/2004 |
K003683 |
JENERIC/PENTRON, INC. |
AVANTE CURELIGHT |
01/11/2001 |
K013500 |
KAVO AMERICA |
KAVO POLYLUX II |
01/14/2002 |
K042888 |
KERR CORP. |
DEMETRON IDS CURING LIGHT |
11/10/2004 |
K014179 |
KERR CORP. |
DEMETRON LC |
02/04/2002 |
K071251 |
KERR CORPORATION |
DEMI |
07/26/2007 |
K163064 |
KERR CORPORATION |
Demi Ultra |
07/18/2017 |
K123468 |
KERR CORPORATION |
DEMI ULTRA |
03/20/2013 |
K102621 |
KERR CORPORATION |
SOLSTICE |
01/28/2011 |
K051545 |
KERR CORPORATION (DANBURY) |
L.E. DEMETRON II |
07/18/2005 |
K020091 |
KERR CORPORATION (DANBURY) |
OPTILUX 501 |
03/21/2002 |
K012946 |
KINETIC INSTRUMENTS, INC. |
SUNLITELED MODEL #2810 |
10/02/2001 |
K022862 |
KINETIC INSTRUMENTS, INC. |
TRANSCURE, MODEL 2910 |
10/18/2002 |
K181597 |
KMIHH Ltd |
Le'Pen |
04/01/2019 |
K994028 |
LOKKI |
FLIPO XENON CURING LIGHT |
01/12/2000 |
K024374 |
LOKKI LASERS MEDICAUX |
RMO PLASMA CURING LIGHT |
03/10/2003 |
K002566 |
LUMALITE, INC. |
LUMALITE CURE LIGHT, MODEL 2100 |
10/19/2000 |
K992236 |
LYSTA A/S |
LYSTA LC COMPACTA CURING LIGHT, MODELS LC 2500 COMPACTA, LC 4000 COMPACTA, LC 6000 COMPACTA & LC 8000 COMPATCA |
08/27/1999 |
K991138 |
LYSTA A/S |
LYSTA LC CURING LIGHT, MODEL LC 2500C/BA |
04/23/1999 |
K092951 |
MECTRON S.P.A. |
STARLIGHT PRO AND SILIVERLIGHT DENTAL CURING LIGHTS |
12/07/2009 |
K993223 |
MEDIPHOTONIX, LC |
RAPICURE 200 (CURING AND WHITENING LIGHT) |
11/01/1999 |
K060646 |
MONITEX INDUSTRIAL CO., LTD. |
BLUE LUXCER CURING LIGHT, MODELS M-830, M-835 AND M-855 |
04/21/2006 |
K051203 |
MONITEX INDUSTRIAL CO., LTD. |
BLUELEX |
05/25/2005 |
K133040 |
MONITEX INDUSTRIAL CO., LTD. |
LED CURING LIGHT |
10/07/2014 |
K152192 |
MONITEX INDUSTRIAL CO., LTD. |
LED Curing Light |
04/07/2017 |
K080035 |
MONITEX INDUSTRIAL CO., LTD. |
LED CURING LIGHT |
03/03/2008 |
K150205 |
MONITEX INDUSTRIAL CO., LTD. |
LED Curing Light |
08/24/2015 |
K161855 |
MONITEX INDUSTRIAL CO., LTD. |
LED Curing Light |
11/27/2017 |
K153078 |
MONITEX INDUSTRIAL CO., LTD. |
LED Curing Light GT-2000 |
06/28/2016 |
K091887 |
MONITEX INDUSTRIAL CO., LTD. |
LED CURING LIGHT, MODEL GT-1500 |
09/18/2009 |
K152936 |
NATIONAL DENTAL INC. |
Sirius Max Dental Diode Curing Light |
11/13/2015 |
K043302 |
NOVA RANGER, INC. |
NOVA-PULSE |
01/03/2005 |
K000393 |
NOVA/DA VINCI SYSTEMS, INC. |
NOVA CORDLESS CURING LIGHT |
03/27/2000 |
K063003 |
PARKELL, INC. |
AURORA |
11/28/2006 |
K061695 |
PENG LIM ENTERPRISE CO., LTD. |
LED PROLUX 770 |
09/14/2006 |
K052349 |
PENTRON CLINICAL TECHNOLOGIES |
AVANTE LED CURING UNIT, MODEL N44 |
10/21/2005 |
K153514 |
PREMIUM PLUS INTERNATIONAL LIMITED |
Premium Plus C01/C02 LED Curing Light |
08/22/2016 |
K172426 |
Promident LLC |
Clear Blue Digi LED Curing Light |
08/16/2017 |
K023652 |
REMEDENT NV |
REMECURE MODEL CL 15E |
01/09/2003 |
K020884 |
ROLENCE ENT. INC. |
EXCELLITE LIGHT CURE UNIT |
06/12/2002 |
K020877 |
ROLENCE ENT. INC. |
EXCELLITE TURBO LIGHT CURE UNIT |
06/12/2002 |
K023545 |
ROLENCE ENT. INC. |
ULTRA-LITE 200E LIGHT CURE UNIT |
12/30/2002 |
K020874 |
ROLENCE ENT. INC. |
ULTRA-LITE 5 TURBO LIGHT CURE UNIT |
06/12/2002 |
K960364 |
ROLENCE ENTERPRISE CO. LTD. |
CU-200 LIGHT CURE UNIT |
04/15/1996 |
K991863 |
ROLENCE ENTERPRISE CO. LTD. |
CUTE-LITE I LIGHT CURE UNIT |
07/19/1999 |
K991865 |
ROLENCE ENTERPRISE CO. LTD. |
Q-LITE 75 LIGHT CURE UNIT |
07/20/1999 |
K960351 |
ROLENCE ENTERPRISE CO. LTD. |
Q-LUX LIGHT CURE UNIT |
04/15/1996 |
K001719 |
ROLENCE ENTERPRISE CO. LTD. |
Q-LUX PLASMA 100 LIGHT CURE UNIT |
10/10/2000 |
K030811 |
SAMM, INC. |
COOL CURE |
06/10/2003 |
K961735 |
SATELEC |
ACTA |
07/31/1996 |
K040808 |
SATELEC |
MINI L.E.D. OEM MODULE |
04/28/2004 |
K032465 |
SATELEC |
MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINI |
10/21/2003 |
K072181 |
SATELEC |
MINI LED AUTOFOCUS |
09/19/2007 |
K131906 |
SATELEC-ACTEON GROUP |
SCANWAVE PEN (WITH LIGHT GRAY CORD), SCANWAVE PEN (WITH MEDIUM GRAY CORD), SCANWAVE PEN (WITH DARK GRAY CORD), SCANWAVE |
04/11/2014 |
K002991 |
SOFT-CORE TEXAS, INC. |
ZAP DUAL CURING LIGHT |
11/28/2000 |
K030568 |
SOUTHERN DENTAL INDUSTRIES, INC. |
RADII |
04/24/2003 |
K992728 |
SPRING HEALTH PRODUCTS, INC. |
SPRING POWERLITE 2000 |
09/29/1999 |
K022265 |
SVENSKA DENTAL INSTRUMENTS AB |
LIGHT TIP |
10/02/2002 |
K063116 |
SYBRON DENTAL SPECIALTIES |
DEMETRON A.2 |
12/05/2006 |
K021797 |
SYBRON DENTAL SPECIALTIES, INC. |
L.E.DEMETRON |
06/27/2002 |
K020267 |
SYBRON DENTAL SPECIALTIES, INC. |
OPTILUX CURING LIGHTS |
03/29/2002 |
K021374 |
TOEI ELECTRIC CO., LTD. |
TOESCO AQUA BLUE LED LIGHT CURING DEVICE |
05/30/2002 |
K210550 |
Ultradent Products, Inc |
VALO Grand Corded and Accessory Lenses |
03/01/2021 |
K003383 |
ULTRADENT PRODUCTS, INC. |
PALMLIGHT |
02/06/2001 |
K110582 |
ULTRADENT PRODUCTS, INC. |
VALO CORDLESS |
04/28/2011 |
K160551 |
ULTRADENT PRODUCTS, INC. |
VALO Grand |
07/13/2016 |
K190627 |
Ultradent Products, Inc. |
VALO Grand Corded |
04/29/2019 |
K220471 |
Ultradent Products, Inc. |
VALO X, VALO X Accessory Lenses |
02/22/2022 |
K083647 |
ULTRADENT PRODUCTS, INC. |
VALO, MODEL 5919 |
01/23/2009 |
K153018 |
VOCO GMBH |
CELALUX 3 |
06/23/2016 |