Activator, Ultraviolet, For Polymerization
Regulation 872.6070
1510(k)s in 12 months (214 all time)
0recalls in 12 months (4 all time)
3recalls that name a 510(k)
Top companies in EBZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Ivoclar Vivadent, AG | 8 | 1 |
| Monitex Industrial Co., Ltd. | 9 | 0 |
| Rolence Enterprise Co. , Ltd. | 8 | 0 |
| Ultradent Products, Inc. | 7 | 0 |
| Kerr Corp. | 6 | 0 |
| Dentsply Intl. | 5 | 0 |
| 3M Company | 4 | 0 |
| Apoza Enterprise Co., Ltd. | 4 | 0 |
| Dentmate Technology Co. , Ltd. | 4 | 0 |
| Dxm Co., Ltd. | 4 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 29, 2011 | K110756 | BLUEPHASE STYLE Ivoclar Vivadent, Inc. | EBZ |
| Apr 28, 2011 | K110582 | VALO CORDLESS Ultradent Products, Inc. | EBZ |
| Jan 28, 2011 | K102621 | SOLSTICE Kerr Corporation | EBZ |
| Feb 24, 2010 | K093751 | CL-DC20, CL-DC21 Good Doctors Co., Ltd. | EBZ |
| Dec 7, 2009 | K092951 | STARLIGHT PRO AND SILIVERLIGHT DENTAL CURING LIGHTS Mectron S.P.A., IT | EBZ |
| Sep 18, 2009 | K091887 | LED CURING LIGHT, MODEL GT-1500 Monitex Industrial Co., Ltd., TW | EBZ |
| Jun 12, 2009 | K091020 | BLUEPHASE 20I Ivoclar Vivadent, Inc. | EBZ |
| Jan 23, 2009 | K083647 | VALO, MODEL 5919 Ultradent Products, Inc. | EBZ |
| Dec 3, 2008 | K082408 | LEDEX, MODEL: WL-070 Dentmate Technology Co. , Ltd., TW | EBZ |
| Nov 21, 2008 | K081287 | SAPPHIRE PLASMA ARC DENTAL CURING LIGHT Den-Mat Holdings, LLC | EBZ |
| Nov 13, 2008 | K082971 | BONART ART-L5 LED CORDLESS CURING LIGHT Bonart Co., Ltd. | EBZ |
| Mar 19, 2008 | K080025 | LED.L, LED.M, LED.G, LED.B Guilin Woodpecker Medical Instrument Co., Ltd. | EBZ |
| Mar 3, 2008 | K080035 | LED CURING LIGHT Monitex Industrial Co., Ltd., TW | EBZ |
| Dec 20, 2007 | K073518 | FLASHLITE REBEL* Discus Dental, Inc. | EBZ |
| Nov 21, 2007 | K072807 | I LIGHT Dent'N CO | EBZ |
| Sep 19, 2007 | K072181 | MINI LED AUTOFOCUS Satelec | EBZ |
| Aug 23, 2007 | K071908 | DOCTOR'S LIGHT LED DENTAL CURING LIGHT Good Doctors Co., Ltd. | EBZ |
| Aug 10, 2007 | K071722 | DEEP BLUE E.M.S Electro Medical Systems S.A | EBZ |
| Jul 26, 2007 | K071251 | DEMI Kerr Corporation | EBZ |
| Apr 30, 2007 | K063659 | EASY CURING PEN-STYLE LED CURING LIGHT Dent Corp. Research & Development | EBZ |
| Mar 2, 2007 | K070373 | APOZA LED CURING LIGHT, MODEL E-MORLIT, D-2000, TOP 3W, TOP 5W Apoza Enterprise Co., Ltd. | EBZ |
| Jan 5, 2007 | K063529 | PENCURE, MODEL VL-7 J. Morita USA, Inc. | EBZ |
| Jan 3, 2007 | K062289 | BONART ART-L3 LED CURING LIGHT Bonart Co., Ltd. | EBZ |
| Dec 5, 2006 | K063116 | DEMETRON A.2 Sybron Dental Specialties | EBZ |
| Nov 28, 2006 | K063003 | AURORA Parkell, Inc. | EBZ |
| Oct 27, 2006 | K062735 | TUTU 7, MODEL IV-T22 Invisible Technology Co., Ltd. | EBZ |
| Sep 18, 2006 | K061658 | SPIRIT, MODEL M, U; DOCPORTMACRO, MODEL M, U, L Dentall Corp. | EBZ |
| Sep 14, 2006 | K061695 | LED PROLUX 770 Peng Lim Enterprise Co., Ltd., TW | EBZ |
| Jun 23, 2006 | K061395 | CALSET COMPOSITE HEATER Addent, Inc. | EBZ |
| Jun 12, 2006 | K061341 | PALMLIGHT 10, MODEL 001-00030 CAO Group, Inc. | EBZ |
| Apr 21, 2006 | K060646 | BLUE LUXCER CURING LIGHT, MODELS M-830, M-835 AND M-855 Monitex Industrial Co., Ltd., TW | EBZ |
| Mar 29, 2006 | K052122 | BISCO LED Bisco, Inc. | EBZ |
| Oct 21, 2005 | K052349 | AVANTE LED CURING UNIT, MODEL N44 Pentron Clinical Technologies | EBZ |
| Sep 28, 2005 | K052593 | FUSION CURING LIGHT Dentlight, Inc. | EBZ |
| Sep 20, 2005 | K051782 | BLUEPHASE 16I Ivoclar Vivadent, Inc. | EBZ |
| Jul 28, 2005 | K051780 | JETLITE 5000 J. Morita USA, Inc. | EBZ |
| Jul 19, 2005 | K051571 | SKYLIGHT LED CURING LIGHT Dmetec.Co., Ltd. | EBZ |
| Jul 18, 2005 | K051545 | L.E. DEMETRON II Kerr Corporation (Danbury) | EBZ |
| May 25, 2005 | K051203 | BLUELEX Monitex Industrial Co., Ltd., TW | EBZ |
| Feb 3, 2005 | K050059 | G-LIGHT GC America, Inc. | EBZ |
| Jan 25, 2005 | K043530 | DVI CURING LIGHT Designs For Vision, Inc. | EBZ |
| Jan 3, 2005 | K043302 | NOVA-PULSE Nova Ranger, Inc. | EBZ |
| Nov 10, 2004 | K042888 | DEMETRON IDS CURING LIGHT Kerr Corp. | EBZ |
| Nov 1, 2004 | K042196 | SAVEDENT BLUE Denfotex Light Systems, Ltd., GB | EBZ |
| Oct 12, 2004 | K042703 | CYBIRD LED CURING LIGHT Dxm Co., Ltd. | EBZ |
| Sep 8, 2004 | K042199 | TRANSLUX POWER BLUE Heraeus Kulzer,GmbH | EBZ |
| Jun 24, 2004 | K041372 | SMARTLITE PS PEN-STYLE LED CURING LIGHT Dentsply International | EBZ |
| Jun 18, 2004 | K041303 | LED TURBO-PEN Apoza Enterprise Co., Ltd., TW | EBZ |
| Jun 14, 2004 | K040956 | HILUX LEDMAX 3 First Medical Infection Control Associates, Inc. | EBZ |
| Apr 28, 2004 | K040808 | MINI L.E.D. OEM MODULE Satelec | EBZ |
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