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 |
|---|---|---|---|
| Nov 1, 1999 | K993223 | RAPICURE 200 (CURING AND WHITENING LIGHT) Mediphotonix, LC | EBZ |
| Sep 29, 1999 | K992728 | SPRING POWERLITE 2000 Spring Health Products, Inc. | EBZ |
| Aug 30, 1999 | K992357 | EASY-CURE (CURING AND WHITENING LIGHT) Ics of North America, Inc. | EBZ |
| Aug 27, 1999 | K992236 | LYSTA LC COMPACTA CURING LIGHT, MODELS LC 2500 COMPACTA, LC 4000 COMPACTA, LC 6000 COMPACTA & LC 8000 COMPATCA Lysta A/S, DK | EBZ |
| Jul 20, 1999 | K991865 | Q-LITE 75 LIGHT CURE UNIT Rolence Enterprise Co. , Ltd., TW | EBZ |
| Jul 19, 1999 | K991863 | CUTE-LITE I LIGHT CURE UNIT Rolence Enterprise Co. , Ltd., TW | EBZ |
| Apr 23, 1999 | K991138 | LYSTA LC CURING LIGHT, MODEL LC 2500C/BA Lysta A/S, DK | EBZ |
| Feb 25, 1999 | K984247 | ELIPAR TRILIGHT Espe Dental AG, DE | EBZ |
| Aug 24, 1998 | K982615 | AIRDENT RADIANCE CURING LIGHT Air Techniques, Inc. | EBZ |
| Jan 6, 1998 | K974369 | APOLLO 9500 Ion Laser Technology | EBZ |
| Aug 29, 1997 | K972355 | 3M AURORA SYSTEM 3M Company | EBZ |
| Jul 10, 1997 | K972006 | ACTA OEM MODULE Interactive Consulting, Inc. | EBZ |
| Jun 4, 1997 | K970506 | HILUX 200,250,275,300,350,500 DENTAL CURING LIGHT Benlioglu Dental Ithalat, Inc., TR | EBZ |
| Mar 18, 1997 | K964524 | ILT ARGON HP Ion Laser Technology | EBZ |
| Oct 24, 1996 | K963110 | JETLITE J. Morita USA, Inc. | EBZ |
| Jul 31, 1996 | K961735 | ACTA Satelec | EBZ |
| Apr 15, 1996 | K960364 | CU-200 LIGHT CURE UNIT Rolence Enterprise Co. , Ltd., TW | EBZ |
| Apr 15, 1996 | K960351 | Q-LUX LIGHT CURE UNIT Rolence Enterprise Co. , Ltd., TW | EBZ |
| Feb 15, 1996 | K953898 | ACL-5500 PRECISION CURING UNIT (PCU) Ion Laser Technology | EBZ |
| Jan 4, 1996 | K955763 | OPTILUX 400 Demetron Research Corp. | EBZ |
| Jan 2, 1996 | K955759 | LITEX 680 Dentamerica | EBZ |
| Sep 21, 1995 | K954061 | POLY-LITE MODEL 1000 Pro-Den Systems, Inc. | EBZ |
| Jun 22, 1995 | K952423 | CU-100RLC LIGHT CURE UNIT, DOCUMENT NO.A715676 Rolence Enterprise Co. , Ltd., TW | EBZ |
| May 31, 1995 | K951465 | SUNLITE 1275 Fen Dental Mfg., Inc. | EBZ |
| May 24, 1995 | K950106 | COLTOLUX LIGHT METER Coltene/Whaledent, Inc. | EBZ |
| May 24, 1995 | K945698 | COLTOLUX 3, COLTOLUX 4 Coltene/Whaledent, Inc. | EBZ |
| May 5, 1995 | K951425 | SPECTRUM CURING LIGHT POLYMERIZATION UNIT Dentsply Intl. | EBZ |
| Jun 2, 1994 | K942199 | CU-100R LIGHT CURE UNIT, DOCUMENT NO. A715676 Rolence Enterprise Co. , Ltd., TW | EBZ |
| May 27, 1994 | K942198 | CU-80 LIGHT CURE UNIT, DOCUMENT NO. A715676 Rolence Enterprise Co. , Ltd., TW | EBZ |
| Jan 6, 1994 | K934746 | 3M CURING LIGHT XL1500 3M Company | EBZ |
| Apr 23, 1993 | K930086 | ORTHOLUX XT 3M Company | EBZ |
| Nov 25, 1992 | K924812 | 3M CURING LIGHT XL 3000 3M Company | EBZ |
| Dec 23, 1991 | K912994 | COMPALUX STROBOSCOPIC LIGHT POLYMERIZATION DEVICE Wilde-USA, Inc. | EBZ |
| Dec 16, 1991 | K913980 | HELIOLUX Ivoclar North America, Inc. | EBZ |
| Mar 15, 1991 | K910068 | SPECTRAMAT Ivoclar North America, Inc. | EBZ |
| Mar 11, 1991 | K905543 | LARES APOLLO CS/CP/C Lares Research, Inc. | EBZ |
| Jul 13, 1990 | K901908 | HELIOLUX VISIBLE CURING LIGHT Ivoclar North America, Inc. | EBZ |
| May 7, 1990 | K900135 | CU-75 VISIBLE LIGHT-CURING UNIT Kab Gloves Unltd. | EBZ |
| Apr 2, 1990 | K895085 | WALKLITE PROTABLE RE-CHARGEABLE CURING LIGHT Lustgarten Multi-Tech International, Inc. | EBZ |
| Aug 21, 1989 | K892517 | TULUX-FILTER Espe GmbH (Us) | EBZ |
| Jun 14, 1989 | K892456 | KULZER TRANSLUX EC Kulzer, Inc. | EBZ |
| Mar 17, 1989 | K884222 | CURING LIGHT COVER Steri-Shield Products, Inc. | EBZ |
| Sep 6, 1988 | K882145 | PHOTO-CURING LIGHT Dentsply Intl. | EBZ |
| Apr 7, 1988 | K880392 | ORTHOLUX VISIBLE LIGHT CURING UNIT Unitek Corp. | EBZ |
| Mar 26, 1986 | K854696 | OP II VISIBLE LIGHT CURING SYSTEM Almore Intl., Inc. | EBZ |
| Jul 9, 1985 | K851915 | CURING LIGHT Technology, Inc. | EBZ |
| Dec 21, 1984 | K844351 | OPTI-LITE Innovators, Inc. | EBZ |
| Dec 11, 1984 | K844325 | COE-LITE POLYMERIZATION UNIT Coe Laboratories, Inc. | EBZ |
| Dec 4, 1984 | K843823 | TRANSLUX CL Kulzer, Inc. | EBZ |
| Aug 31, 1983 | K832320 | PRISMA III Dentsply Intl. | EBZ |
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