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 |
|---|---|---|---|
| Apr 7, 2004 | K040614 | BLUEWAND LED DENTAL CURING WAND SYSTEM J.L. Blosser, Inc. | EBZ |
| Mar 25, 2004 | K040618 | LED TURBO Apoza Enterprise Co., Ltd., TW | EBZ |
| Mar 15, 2004 | K040551 | COLTOLUX LED CURING LIGHT Coltene/Whaledent, Inc. | EBZ |
| Feb 27, 2004 | K033697 | POWER LED Dental Products of USA, Inc. | EBZ |
| Dec 19, 2003 | K033795 | PLASMACURE BXE Eele Laboratories, LLC | EBZ |
| Dec 5, 2003 | K033520 | BLUEPHASE Ivoclar Vivadent, Inc. | EBZ |
| Dec 2, 2003 | K033201 | LA500 BLUE LIGHT Apoza Enterprise Co., Ltd., TW | EBZ |
| Oct 27, 2003 | K032099 | SWISS MASTER LIGHT (Ems Sa) Electro Medical Systems | EBZ |
| Oct 21, 2003 | K032465 | MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINI Satelec | EBZ |
| Jul 21, 2003 | K031615 | SLED CURING LIGHT SYSTEM Dentsply International | EBZ |
| Jun 10, 2003 | K030811 | COOL CURE Samm, Inc. | EBZ |
| Jun 10, 2003 | K030641 | CONTEC LIGHT Dentaurum | EBZ |
| Apr 24, 2003 | K030568 | RADII Southern Dental Industries, Inc. | EBZ |
| Mar 10, 2003 | K024374 | RMO PLASMA CURING LIGHT Lokki Lasers Medicaux | EBZ |
| Jan 17, 2003 | K023748 | FLASH-LITE II LED DENTAL CURING LIGHT Discus Dental, Inc. | EBZ |
| Jan 10, 2003 | K023721 | BONART ART-L2 LIGHT CURING UNIT Bonart Co., Ltd. | EBZ |
| Jan 9, 2003 | K023652 | REMECURE MODEL CL 15E Remedent NV | EBZ |
| Dec 30, 2002 | K023545 | ULTRA-LITE 200E LIGHT CURE UNIT Rolence Ent., Inc., TW | EBZ |
| Oct 18, 2002 | K022862 | TRANSCURE, MODEL 2910 Kinetic Instruments, Inc. | EBZ |
| Oct 2, 2002 | K022265 | LIGHT TIP Svenska Dental Instruments AB, SE | EBZ |
| Aug 27, 2002 | K020057 | PALMLIGHT CAO Group, Inc. | EBZ |
| Aug 20, 2002 | K022184 | FLASH-LITE LED DENTAL CURING LIGHT Discus Dental, Inc. | EBZ |
| Jun 27, 2002 | K021797 | L.E.DEMETRON Sybron Dental Specialties, Inc. | EBZ |
| Jun 12, 2002 | K020884 | EXCELLITE LIGHT CURE UNIT Rolence Ent., Inc., TW | EBZ |
| Jun 12, 2002 | K020877 | EXCELLITE TURBO LIGHT CURE UNIT Rolence Ent., Inc., TW | EBZ |
| Jun 12, 2002 | K020874 | ULTRA-LITE 5 TURBO LIGHT CURE UNIT Rolence Ent., Inc., TW | EBZ |
| May 30, 2002 | K021374 | TOESCO AQUA BLUE LED LIGHT CURING DEVICE Toei Electric Co., Ltd. | EBZ |
| Mar 29, 2002 | K020267 | OPTILUX CURING LIGHTS Sybron Dental Specialties, Inc. | EBZ |
| Mar 21, 2002 | K020091 | OPTILUX 501 Kerr Corporation (Danbury) | EBZ |
| Feb 4, 2002 | K014179 | DEMETRON LC Kerr Corp. | EBZ |
| Jan 29, 2002 | K020171 | COOLBLU2 DENTAL RESIN CURING DEVICE Dental Systems.Com, Inc. | EBZ |
| Jan 14, 2002 | K013500 | KAVO POLYLUX II Kavo America | EBZ |
| Oct 22, 2001 | K013277 | ASTRALIS 7, MODEL 557545 Ivoclar Vivadent, Inc. | EBZ |
| Oct 19, 2001 | K013275 | ASTRALIS 10, MODELS # 559588, 561859 Ivoclar Vivadent, Inc. | EBZ |
| Oct 2, 2001 | K012946 | SUNLITELED MODEL #2810 Kinetic Instruments, Inc. | EBZ |
| Aug 30, 2001 | K012341 | TRANSLUX ENERGY Heraeus Kulzer, Inc. | EBZ |
| Aug 7, 2001 | K012134 | GC E-LIGHT GC America, Inc. | EBZ |
| May 16, 2001 | K011154 | ELIPAR FREELIGHT Espe Dental AG, DE | EBZ |
| Apr 5, 2001 | K010133 | VERSALUX Centrix, Inc. | EBZ |
| Feb 6, 2001 | K003383 | PALMLIGHT Ultradent Products, Inc. | EBZ |
| Jan 11, 2001 | K003683 | AVANTE CURELIGHT Jeneric/Pentron, Inc. | EBZ |
| Dec 20, 2000 | K002925 | COOLBLU CURING LIGHT Dental Systems.Com, Inc. | EBZ |
| Nov 28, 2000 | K002991 | ZAP DUAL CURING LIGHT Soft-Core Texas, Inc. | EBZ |
| Oct 19, 2000 | K002566 | LUMALITE CURE LIGHT, MODEL 2100 Lumalite, Inc. | EBZ |
| Oct 10, 2000 | K001719 | Q-LUX PLASMA 100 LIGHT CURE UNIT Rolence Enterprise Co. , Ltd., TW | EBZ |
| May 15, 2000 | K000078 | JETLITE 4000 J. Morita USA, Inc. | EBZ |
| Apr 12, 2000 | K000426 | VIP- VARIABLE INTENSITY POLYMERIZER Bisco, Inc. | EBZ |
| Mar 27, 2000 | K000393 | NOVA CORDLESS CURING LIGHT Nova/Da Vinci Systems, Inc. | EBZ |
| Jan 13, 2000 | K994048 | PORTABLE LIGHT CURING UNIT Gregory S. Jacob, D.D.S. | EBZ |
| Jan 12, 2000 | K994028 | FLIPO XENON CURING LIGHT Lokki | EBZ |
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