FDA Product Code
FDA Product Code EBZ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.6070
510(k) Clearances — 214 records · page 2 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K040614 | BLUEWAND LED DENTAL CURING WAND SYSTEM | J.L. Blosser, Inc. | 2004-04-07 | Traditional | PDF ↗ |
| K040618 | LED TURBO | Apoza Enterprise Co., Ltd. | 2004-03-25 | Traditional | PDF ↗ |
| K040551 | COLTOLUX LED CURING LIGHT | Coltene/Whaledent, Inc. | 2004-03-15 | Traditional | PDF ↗ |
| K033697 | POWER LED | Dental Products of USA, Inc. | 2004-02-27 | Traditional | PDF ↗ |
| K033795 | PLASMACURE BXE | Eele Laboratories, LLC | 2003-12-19 | Traditional | PDF ↗ |
| K033520 | BLUEPHASE | Ivoclar Vivadent, Inc. | 2003-12-05 | Traditional | PDF ↗ |
| K033201 | LA500 BLUE LIGHT | Apoza Enterprise Co., Ltd. | 2003-12-02 | Traditional | PDF ↗ |
| K032099 | SWISS MASTER LIGHT | (Ems Sa) Electro Medical Systems | 2003-10-27 | Traditional | PDF ↗ |
| K032465 | MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINI | Satelec | 2003-10-21 | Traditional | PDF ↗ |
| K031615 | SLED CURING LIGHT SYSTEM | Dentsply International | 2003-07-21 | Traditional | PDF ↗ |
| K030811 | COOL CURE | Samm, Inc. | 2003-06-10 | Traditional | PDF ↗ |
| K030641 | CONTEC LIGHT | Dentaurum | 2003-06-10 | Traditional | PDF ↗ |
| K030568 | RADII | Southern Dental Industries, Inc. | 2003-04-24 | Traditional | PDF ↗ |
| K024374 | RMO PLASMA CURING LIGHT | Lokki Lasers Medicaux | 2003-03-10 | Traditional | PDF ↗ |
| K023748 | FLASH-LITE II LED DENTAL CURING LIGHT | Discus Dental, Inc. | 2003-01-17 | Traditional | PDF ↗ |
| K023721 | BONART ART-L2 LIGHT CURING UNIT | Bonart Co., Ltd. | 2003-01-10 | Traditional | PDF ↗ |
| K023652 | REMECURE MODEL CL 15E | Remedent NV | 2003-01-09 | Traditional | PDF ↗ |
| K023545 | ULTRA-LITE 200E LIGHT CURE UNIT | Rolence Ent., Inc. | 2002-12-30 | Traditional | PDF ↗ |
| K022862 | TRANSCURE, MODEL 2910 | Kinetic Instruments, Inc. | 2002-10-18 | Traditional | PDF ↗ |
| K022265 | LIGHT TIP | Svenska Dental Instruments AB | 2002-10-02 | Traditional | PDF ↗ |
| K020057 | PALMLIGHT | CAO Group, Inc. | 2002-08-27 | Traditional | PDF ↗ |
| K022184 | FLASH-LITE LED DENTAL CURING LIGHT | Discus Dental, Inc. | 2002-08-20 | Traditional | PDF ↗ |
| K021797 | L.E.DEMETRON | Sybron Dental Specialties, Inc. | 2002-06-27 | Traditional | PDF ↗ |
| K020874 | ULTRA-LITE 5 TURBO LIGHT CURE UNIT | Rolence Ent., Inc. | 2002-06-12 | Traditional | PDF ↗ |
| K020884 | EXCELLITE LIGHT CURE UNIT | Rolence Ent., Inc. | 2002-06-12 | Traditional | PDF ↗ |
| K020877 | EXCELLITE TURBO LIGHT CURE UNIT | Rolence Ent., Inc. | 2002-06-12 | Traditional | PDF ↗ |
| K021374 | TOESCO AQUA BLUE LED LIGHT CURING DEVICE | Toei Electric Co., Ltd. | 2002-05-30 | Traditional | PDF ↗ |
| K020267 | OPTILUX CURING LIGHTS | Sybron Dental Specialties, Inc. | 2002-03-29 | Traditional | PDF ↗ |
| K020091 | OPTILUX 501 | Kerr Corporation (Danbury) | 2002-03-21 | Traditional | PDF ↗ |
| K014179 | DEMETRON LC | Kerr Corp. | 2002-02-04 | Traditional | PDF ↗ |
| K020171 | COOLBLU2 DENTAL RESIN CURING DEVICE | Dental Systems.Com, Inc. | 2002-01-29 | Special | PDF ↗ |
| K013500 | KAVO POLYLUX II | Kavo America | 2002-01-14 | Traditional | PDF ↗ |
| K013277 | ASTRALIS 7, MODEL 557545 | Ivoclar Vivadent, Inc. | 2001-10-22 | Traditional | PDF ↗ |
| K013275 | ASTRALIS 10, MODELS # 559588, 561859 | Ivoclar Vivadent, Inc. | 2001-10-19 | Traditional | PDF ↗ |
| K012946 | SUNLITELED MODEL #2810 | Kinetic Instruments, Inc. | 2001-10-02 | Traditional | PDF ↗ |
| K012341 | TRANSLUX ENERGY | Heraeus Kulzer, Inc. | 2001-08-30 | Traditional | PDF ↗ |
| K012134 | GC E-LIGHT | GC America, Inc. | 2001-08-07 | Traditional | PDF ↗ |
| K011154 | ELIPAR FREELIGHT | Espe Dental AG | 2001-05-16 | Traditional | PDF ↗ |
| K010133 | VERSALUX | Centrix, Inc. | 2001-04-05 | Traditional | PDF ↗ |
| K003383 | PALMLIGHT | Ultradent Products, Inc. | 2001-02-06 | Traditional | PDF ↗ |
| K003683 | AVANTE CURELIGHT | Jeneric/Pentron, Inc. | 2001-01-11 | Traditional | PDF ↗ |
| K002925 | COOLBLU CURING LIGHT | Dental Systems.Com, Inc. | 2000-12-20 | Traditional | PDF ↗ |
| K002991 | ZAP DUAL CURING LIGHT | Soft-Core Texas, Inc. | 2000-11-28 | Traditional | PDF ↗ |
| K002566 | LUMALITE CURE LIGHT, MODEL 2100 | Lumalite, Inc. | 2000-10-19 | Traditional | PDF ↗ |
| K001719 | Q-LUX PLASMA 100 LIGHT CURE UNIT | Rolence Enterprise Co. , Ltd. | 2000-10-10 | Traditional | PDF ↗ |
| K000078 | JETLITE 4000 | J. Morita USA, Inc. | 2000-05-15 | Traditional | PDF ↗ |
| K000426 | VIP- VARIABLE INTENSITY POLYMERIZER | Bisco, Inc. | 2000-04-12 | Traditional | PDF ↗ |
| K000393 | NOVA CORDLESS CURING LIGHT | Nova/Da Vinci Systems, Inc. | 2000-03-27 | Traditional | PDF ↗ |
| K994048 | PORTABLE LIGHT CURING UNIT | Gregory S. Jacob, D.D.S. | 2000-01-13 | Traditional | PDF ↗ |
| K994028 | FLIPO XENON CURING LIGHT | Lokki | 2000-01-12 | Traditional | PDF ↗ |
| K993223 | RAPICURE 200 (CURING AND WHITENING LIGHT) | Mediphotonix, LC | 1999-11-01 | Traditional | PDF ↗ |
| K992728 | SPRING POWERLITE 2000 | Spring Health Products, Inc. | 1999-09-29 | Traditional | PDF ↗ |
| K992357 | EASY-CURE (CURING AND WHITENING LIGHT) | Ics of North America, Inc. | 1999-08-30 | Traditional | PDF ↗ |
| K992236 | LYSTA LC COMPACTA CURING LIGHT, MODELS LC 2500 COMPACTA, LC 4000 COMPACTA, LC 6000 COMPACTA & LC 8000 COMPATCA | Lysta A/S | 1999-08-27 | Traditional | PDF ↗ |
| K991865 | Q-LITE 75 LIGHT CURE UNIT | Rolence Enterprise Co. , Ltd. | 1999-07-20 | Traditional | PDF ↗ |
| K991863 | CUTE-LITE I LIGHT CURE UNIT | Rolence Enterprise Co. , Ltd. | 1999-07-19 | Traditional | PDF ↗ |
| K991138 | LYSTA LC CURING LIGHT, MODEL LC 2500C/BA | Lysta A/S | 1999-04-23 | Traditional | PDF ↗ |
| K984247 | ELIPAR TRILIGHT | Espe Dental AG | 1999-02-25 | Traditional | PDF ↗ |
| K982615 | AIRDENT RADIANCE CURING LIGHT | Air Techniques, Inc. | 1998-08-24 | Traditional | PDF ↗ |
| K974369 | APOLLO 9500 | Ion Laser Technology | 1998-01-06 | Traditional | PDF ↗ |
| K972355 | 3M AURORA SYSTEM | 3M Company | 1997-08-29 | Traditional | PDF ↗ |
| K972006 | ACTA OEM MODULE | Interactive Consulting, Inc. | 1997-07-10 | Traditional | PDF ↗ |
| K970506 | HILUX 200,250,275,300,350,500 DENTAL CURING LIGHT | Benlioglu Dental Ithalat, Inc. | 1997-06-04 | Traditional | PDF ↗ |
| K964524 | ILT ARGON HP | Ion Laser Technology | 1997-03-18 | Traditional | PDF ↗ |
| K963110 | JETLITE | J. Morita USA, Inc. | 1996-10-24 | Traditional | PDF ↗ |
| K961735 | ACTA | Satelec | 1996-07-31 | Traditional | PDF ↗ |
| K960351 | Q-LUX LIGHT CURE UNIT | Rolence Enterprise Co. , Ltd. | 1996-04-15 | Traditional | PDF ↗ |
| K960364 | CU-200 LIGHT CURE UNIT | Rolence Enterprise Co. , Ltd. | 1996-04-15 | Traditional | PDF ↗ |
| K953898 | ACL-5500 PRECISION CURING UNIT (PCU) | Ion Laser Technology | 1996-02-15 | Traditional | PDF ↗ |
| K955763 | OPTILUX 400 | Demetron Research Corp. | 1996-01-04 | Traditional | PDF ↗ |
| K955759 | LITEX 680 | Dentamerica | 1996-01-02 | Traditional | PDF ↗ |
| K954061 | POLY-LITE MODEL 1000 | Pro-Den Systems, Inc. | 1995-09-21 | Traditional | PDF ↗ |
| K952423 | CU-100RLC LIGHT CURE UNIT, DOCUMENT NO.A715676 | Rolence Enterprise Co. , Ltd. | 1995-06-22 | Traditional | PDF ↗ |
| K951465 | SUNLITE 1275 | Fen Dental Mfg., Inc. | 1995-05-31 | Traditional | PDF ↗ |
| K945698 | COLTOLUX 3, COLTOLUX 4 | Coltene/Whaledent, Inc. | 1995-05-24 | Traditional | PDF ↗ |
| K950106 | COLTOLUX LIGHT METER | Coltene/Whaledent, Inc. | 1995-05-24 | Traditional | PDF ↗ |
| K951425 | SPECTRUM CURING LIGHT POLYMERIZATION UNIT | Dentsply Intl. | 1995-05-05 | Traditional | PDF ↗ |
| K942199 | CU-100R LIGHT CURE UNIT, DOCUMENT NO. A715676 | Rolence Enterprise Co. , Ltd. | 1994-06-02 | Traditional | PDF ↗ |
| K942198 | CU-80 LIGHT CURE UNIT, DOCUMENT NO. A715676 | Rolence Enterprise Co. , Ltd. | 1994-05-27 | Traditional | PDF ↗ |
| K934746 | 3M CURING LIGHT XL1500 | 3M Company | 1994-01-06 | Traditional | PDF ↗ |
| K930086 | ORTHOLUX XT | 3M Company | 1993-04-23 | Traditional | PDF ↗ |
| K924812 | 3M CURING LIGHT XL 3000 | 3M Company | 1992-11-25 | Traditional | PDF ↗ |
| K912994 | COMPALUX STROBOSCOPIC LIGHT POLYMERIZATION DEVICE | Wilde-USA, Inc. | 1991-12-23 | Traditional | PDF ↗ |
| K913980 | HELIOLUX | Ivoclar North America, Inc. | 1991-12-16 | Traditional | PDF ↗ |
| K910068 | SPECTRAMAT | Ivoclar North America, Inc. | 1991-03-15 | Traditional | PDF ↗ |
| K905543 | LARES APOLLO CS/CP/C | Lares Research, Inc. | 1991-03-11 | Traditional | PDF ↗ |
| K901908 | HELIOLUX VISIBLE CURING LIGHT | Ivoclar North America, Inc. | 1990-07-13 | Traditional | PDF ↗ |
| K900135 | CU-75 VISIBLE LIGHT-CURING UNIT | Kab Gloves Unltd. | 1990-05-07 | Traditional | PDF ↗ |
| K895085 | WALKLITE PROTABLE RE-CHARGEABLE CURING LIGHT | Lustgarten Multi-Tech International, Inc. | 1990-04-02 | Traditional | PDF ↗ |
| K892517 | TULUX-FILTER | Espe GmbH (Us) | 1989-08-21 | Traditional | PDF ↗ |
| K892456 | KULZER TRANSLUX EC | Kulzer, Inc. | 1989-06-14 | Traditional | PDF ↗ |
| K884222 | CURING LIGHT COVER | Steri-Shield Products, Inc. | 1989-03-17 | Traditional | PDF ↗ |
| K882145 | PHOTO-CURING LIGHT | Dentsply Intl. | 1988-09-06 | Traditional | PDF ↗ |
| K880392 | ORTHOLUX VISIBLE LIGHT CURING UNIT | Unitek Corp. | 1988-04-07 | Traditional | PDF ↗ |
| K854696 | OP II VISIBLE LIGHT CURING SYSTEM | Almore Intl., Inc. | 1986-03-26 | Traditional | PDF ↗ |
| K851915 | CURING LIGHT | Technology, Inc. | 1985-07-09 | Traditional | PDF ↗ |
| K844351 | OPTI-LITE | Innovators, Inc. | 1984-12-21 | Traditional | PDF ↗ |
| K844325 | COE-LITE POLYMERIZATION UNIT | Coe Laboratories, Inc. | 1984-12-11 | Traditional | PDF ↗ |
| K843823 | TRANSLUX CL | Kulzer, Inc. | 1984-12-04 | Traditional | PDF ↗ |
| K832320 | PRISMA III | Dentsply Intl. | 1983-08-31 | Traditional | PDF ↗ |
Product code EBZ · Class II · Dental. Data: openFDA.