FDA 510(k) Applications for Medical Device:
Activator, Ultraviolet, For Polymerization
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K032099 | (EMS SA) ELECTRO MEDICAL SYSTEMS |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K972355 | 3M COMPANY |
3M CENTER | ST. PAUL | MN | 55144-1000 |
| K061395 | ADDENT, INC. |
43 MIRY BROOK RD. | DANBURY | CT | 06810 |
| K982615 | AIR TECHNIQUES, INC. |
70 CANTIAGUE ROCK RD. | HICKSVILLE | NY | 11802 |
| K070373 | APOZA ENTERPRISE CO. LTD. |
2904 N. BOLDT DR. | FLAGSTAFF | AZ | 86001 |
| K033201 | APOZA ENTERPRISE CO. LTD. |
6 F,NO.657, CHUANG CHENG ROAD | TAIPEI HSIEN | 242 | |
| K040618 | APOZA ENTERPRISE CO. LTD. |
6 F,NO. 657, CHUNG-CHENG ROAD | TAIPEI HSIEN | 242 | |
| K041303 | APOZA ENTERPRISE CO. LTD. |
6 F,NO.657, CHUANG CHENG ROAD | TAIPEI HSIEN | 242 | |
| K970506 | BENLIOGLU DENTAL ITHALAT INC. |
BINNAZ SK. 1/6 KAVAKLIDERE | ANKARA | ||
| K052122 | BISCO, INC. |
1100 WEST IRVING PARK RD. | SCHAUMBURG | IL | 60193 |
| K000426 | BISCO, INC. |
1100 WEST IRVING PARK RD. | SCHAUMBURG | IL | 60193 |
| K023721 | BONART CO. LTD. |
398 S. LEMON CREEK DR. | WALNUT | CA | 91789 |
| K062289 | BONART CO. LTD. |
398 S. LEMON CREEK DR. | WALNUT | CA | 91789 |
| K082971 | BONART CO. LTD. |
398 S. LEMON CREEK DR. | WALNUT | CA | 91789 |
| K150585 | CAO GROUP, INC. |
4628 WEST SKYHAWK DRIVE | WEST JORDAN | UT | 84084 |
| K020057 | CAO GROUP, INC. |
8685 SOUTH 7TH WEST | SANDY | UT | 84070 |
| K061341 | CAO GROUP, INC. |
8683 SOUTH 700 WEST | SANDY | UT | 84070 |
| K010133 | CENTRIX, INC. |
770 RIVER RD. | SHELTON | CT | 06484-5458 |
| K221152 | Changzhou Sifary Medical Technology Co., Ltd. |
No. 99, Qingyang Road, Xuejia County, Xinbei District | Changzhou | 213000 | |
| K040551 | COLTENE/WHALEDENT INC. |
1349 LEXINGTON AVE. | NEW YORK | NY | 10128 |
| K955763 | DEMETRON RESEARCH CORP. |
1332 SOUTH LONE HILL AVE. | GLENDORA | CA | 91740 |
| K081287 | DEN-MAT HOLDINGS, LLC |
2727 SKYWAY DR. | SANTA MARIA | CA | 93455 |
| K042196 | DENFOTEX LIGHT SYSTEMS LTD |
UNIT 15, BELLEKNOWES IND.EST | INVERKEITHING FIFE, SCOTLAND | KY11 1H7 | |
| K063659 | DENT CORP. RESEARCH & DEVELOPMENT |
7-11 SOUTH BROADWAY | WHITE PLAINS | NY | 10601 |
| K072807 | DENT'N CO |
11440 WEST BERNARDO CT. | SAN DIEGO | CA | 92127 |
| K223142 | Dent4You AG |
Bahnhofstrasse 2 | Heerbrugg | 9435 | |
| K033697 | DENTAL PRODUCTS OF USA, INC. |
1460 N.W. 107 AVE., SUITE G | MIAMI | FL | 33174 |
| K002925 | DENTAL SYSTEMS.COM, INC. |
1187 TADSWORTH TRAIL | HEATHROW | FL | 32746 |
| K020171 | DENTAL SYSTEMS.COM, INC. |
1187 TADSWORTH TERRACE | HEATHROW | FL | 32746 |
| K170529 | DENTALL Co., Ltd. |
301-905, Bucheontechnopark, 345, Seokcheon-ro, Ojeong-gu | Bucheon-si | 14501 | |
| K061658 | DENTALL CORP. |
3 FARADAY #B | IRVINE | CA | 92618 |
| K140432 | DENTALL CORPORATION |
2651 E CHAPMAN AVE. SUITE 110 | FULLERTON | CA | 92831 |
| K955759 | DENTAMERICA |
18320 BEDFORD CIRCLE | INDUSTRY | CA | 91744 |
| K030641 | DENTAURUM |
10 PHEASANT RUN | NEWTOWN | PA | 18940 |
| K052593 | DENTLIGHT INC. |
4404 BRECKINRIDGE BLVD. | RICHARDSON | TX | 75082 |
| K180065 | DentLight Inc. |
1825 Summit Ave. Ste 210 | Plano | TX | 75074 |
| K221194 | Dentmate Technology Co. Ltd. |
8F, No.8-11, Sec. 1, Zhongxing Road, | New Taipei | 24872 | |
| K131042 | DENTMATE TECHNOLOGY CO., LTD. |
8F, No.8-11, Sec.1, Zhongxing Road, | New Taipei City | 24872 | |
| K163605 | DENTMATE TECHNOLOGY CO., LTD. |
8F, No.8-11, Sec.1, Zhongxing Road, | New Taipei | 24872 | |
| K082408 | DENTMATE TECHNOLOGY CO., LTD. |
NO. 80-1, LANE 160, SEC. 4 | SANCHUNG | 241 | |
| K031615 | DENTSPLY INTERNATIONAL |
570 WEST COLLEGE AVE. | YORK | PA | 17405-0872 |
| K041372 | DENTSPLY INTERNATIONAL |
221 WEST PHILADELPHIA ST. | YORK | PA | 17404 |
| K191865 | Dentsply Sirona |
221 West Philadelphia Street, Suite 60W | York | PA | 17401 |
| K043530 | DESIGNS FOR VISION, INC. |
49 PLAIN STREET | NORTH ATTLEBORO | MA | 02760 |
| K130163 | DIADENT GROUP INTERNATIONAL |
626, YEONJE-RI, GANGOE-MYEON | CHUNGCHEONG BUK-DO | 363-951 | |
| K200809 | Diadent Group International |
16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu | Cheongji-si | 28161 | |
| K023748 | DISCUS DENTAL, INC. |
8550 HIGUERA ST. | CULVER CITY | CA | 90232-2522 |
| K022184 | DISCUS DENTAL, INC. |
8550 HIGUERA ST. | CULVER CITY | CA | 90232-2522 |
| K073518 | DISCUS DENTAL, INC. |
8550 HIGUERA ST. | CULVER CITY | CA | 90232-2522 |
| K051571 | DMETEC CO., LTD. |
55 NORTHERN BLVD., SUITE 200 | GREAT NECK | NY | 11021 |
| K173876 | DXM Co., Ltd |
Baekseok-dong, Ilsan technotown 1003, 138, Ilsan-ro, | Goyang-si | 411-360 | |
| K191221 | DXM Co., Ltd |
Baekseok-dong, Ilsan technotown 1003, 138, Ilsan-ro, | Goyang-si | 411-360 | |
| K042703 | DXM CO., LTD. |
55 Northern Blvd. | Great Neck | NY | 11021 |
| K121093 | DXM CO., LTD. |
55 NORTHERN BLVD. | GREAT NECK | NY | 11021 |
| K071722 | E.M.S. ELECTRO MEDICAL SYSTEMS S.A. |
49 PLAIN STREET | NORTH ATTLEBORO | MA | 02760 |
| K033795 | EELE LABORATORIES, LLC |
50 ORVILLE DRIVE | BOHEMIA | NY | 11716 |
| K140281 | EPIC MEDICAL CONCEPTS & INNOVATIONS |
6950 SQUIBB RD, STE 300 | MISSION | KS | 66202 |
| K011154 | ESPE DENTAL AG |
ESPE PLATZ | SEEFELD, BAVARIA | D-82229 | |
| K984247 | ESPE DENTAL AG |
ESPE PLATZ | SEEFELD, BAVARIA | D-82229 | |
| K192009 | EZGO Group Inc. |
8840 Flower Rd 120 | Rancho Cucamonga | CA | 91730 |
| K040956 | FIRST MEDICAL INFECTION CONTROL ASSOCIATES, INC. |
3704-C BOREN DR. | GREENSBORO | NC | 27407 |
| K192233 | Foshan CICADA Dental Instrument Co., Ltd. |
B5-2F, Guangdong New Light Source Industrial Base | Foshan | ||
| K220826 | Foshan COXO Medical Instrument Co., Ltd. |
BLDG 4, District A, Guangdong New Light Source Industrial | Nanhai District, Foshan | 528226 | |
| K200775 | Garrison Dental Solutions, LLC |
150 DeWitt Lane | Spring Lake | MI | 49456 |
| K050059 | GC AMERICA, INC. |
3737 WEST 127TH ST. | ALSIP | IL | 60803 |
| K012134 | GC AMERICA, INC. |
3737 WEST 127TH ST. | ALSIP | IL | 60803 |
| K093751 | GOOD DOCTORS CO., LTD. |
5401 S. COTTONWOOD CT | GREENWOOD VILLAGE | CO | 80121 |
| K223507 | Good Doctors Co., Ltd. |
#208, B-Dong, 283 Bupyeong-Daero, Bupyeong-Gu | Incheon | 21315 | |
| K071908 | GOOD DOCTORS CO., LTD. |
1705 S. CAPITAL OF TEXAS HWY | AUSTIN | TX | 78746 |
| K173157 | Good Doctors Co.,Ltd. |
#208, B-Dong, 283 Bupyeong-Daero, Bupyeong-Gu | Incheon | 21315 | |
| K994048 | GREGORY S. JACOB, D.D.S. |
9672 READING CIRCLE | DES PLAINS | IL | 60016 |
| K080025 | GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD |
340 SHADY GROVE ROAD | FLINTVILLE | TN | 37335 |
| K042199 | HERAEUS KULZER GMBH |
4315 SOUTH LAFAYETTE BLVD. | SOUTH BEND | IN | 46614-2517 |
| K012341 | HERAEUS KULZER, INC. |
4315 SOUTH LAFAYETTE BLVD. | SOUTH BEND | IN | 46614-2517 |
| K992357 | ICS OF NORTH AMERICA, INC. |
10054 MESA RIDGE CT. | SAN DIEGO | CA | 92121 |
| K170101 | Inter-Med / Vista Dental Products |
2200 South St. Ste. A | Racine | WI | 53404 |
| K972006 | INTERACTIVE CONSULTING, INC. |
70 Walnut Street | Wellesley | MA | 02481 |
| K062735 | INVISIBLE TECHNOLOGY CO., LTD. |
11460 N. MERIDIAN ST. | CARMEL | IN | 46032 |
| K953898 | ION LASER TECHNOLOGY |
3828 SOUTH MAIN ST. | SALT LAKE CITY | UT | 84115 |
| K974369 | ION LASER TECHNOLOGY |
3828 SOUTH MAIN ST. | SALT LAKE CITY | UT | 84115 |
| K964524 | ION LASER TECHNOLOGY |
3828 SOUTH MAIN ST. | SALT LAKE CITY | UT | 84115 |
| K190272 | Ivoclar Vivadent, AG |
Bendererstrasse 2 | Schaan | FL-9494 | |
| K163613 | IVOCLAR VIVADENT, AG |
BENDERERSTRASSE 2 | SCHAAN | FL-9494 | |
| K013275 | IVOCLAR VIVADENT, INC. |
175 PINEVIEW DR. | AMHERST | NY | 14228 |
| K013277 | IVOCLAR VIVADENT, INC. |
175 PINEVIEW DR. | AMHERST | NY | 14228 |
| K033520 | IVOCLAR VIVADENT, INC. |
175 PINEVIEW DR. | AMHERST | NY | 14228 |
| K051782 | IVOCLAR VIVADENT, INC. |
175 PINEVIEW DR. | AMHERST | NY | 14228 |
| K091020 | IVOCLAR VIVADENT, INC. |
175 PINEVIEW DR. | AMHERST | NY | 14228 |
| K110756 | IVOCLAR VIVADENT, INC. |
175 PINEVIEW DR. | AMHERST | NY | 14228 |
| K963110 | J. MORITA USA, INC. |
601 13TH STREET, N.W. | WASHINGTON | DC | 20005 |
| K000078 | J. MORITA USA, INC. |
601 13TH STREET, N.W. | WASHINGTON | DC | 20005 |
| K051780 | J. MORITA USA, INC. |
9 MASON | IRVINE | CA | 92618 |
| K063529 | J. MORITA USA, INC. |
1425 K STREET NW | WASHINGTON | DC | 20005 |
| K040614 | J.L. BLOSSER, INC. |
22 NORTH MAIN ST. | LIBERTY | MO | 64068 |
| K003683 | JENERIC/PENTRON, INC. |
53 NORTH PLAINS INDUSTRIAL RD. | WALLINGFORD | CT | 06492-0724 |
| K013500 | KAVO AMERICA |
340 EAST MAIN ST. | LAKE ZURICH | IL | 60047 |
| K042888 | KERR CORP. |
1717 WEST COLLINS AVE. | ORANGE | CA | 92867 |
| K014179 | KERR CORP. |
1717 WEST COLLINS AVE. | ORANGE | CA | 92867 |
| K071251 | KERR CORPORATION |
1717 WEST COLLINS AVENUE | ORANGE | CA | 92867 |
| K163064 | KERR CORPORATION |
1717 W. COLLINS AVE | ORANGE | CA | 92867 |
| K123468 | KERR CORPORATION |
1717 WEST COLLINS AVENUE | ORANGE | CA | 92867 |
| K102621 | KERR CORPORATION |
1717 WEST COLLINS AVENUE | ORANGE | CA | 92867 |
| K051545 | KERR CORPORATION (DANBURY) |
1717 WEST COLLINS AVE. | ORANGE | CA | 92867 |
| K020091 | KERR CORPORATION (DANBURY) |
1717 WEST COLLINS AVE. | ORANGE | CA | 92867 |
| K012946 | KINETIC INSTRUMENTS, INC. |
17 BERKSHIRE BLVD. | BETHEL | CT | 06801 |
| K022862 | KINETIC INSTRUMENTS, INC. |
17 BERKSHIRE BLVD. | BETHEL | CT | 06801 |
| K181597 | KMIHH Ltd |
9 Hamovil Str., | Kfar-Saba | 4442411 | |
| K994028 | LOKKI |
344 ANNABELLE POINT RD. | CENTERVILLE | MA | 02632 |
| K024374 | LOKKI LASERS MEDICAUX |
344 ANNABELLE POINT RD. | CENTERVILLE | MA | 02632-2402 |
| K002566 | LUMALITE, INC. |
2810 VIA ORANGE WAY, STE. B | SPRING VALLEY | CA | 91978 |
| K992236 | LYSTA A/S |
GAMMELGAARDSVEJ 102 | FARUM | DK-3520 | |
| K991138 | LYSTA A/S |
GAMMELGAARDSVEJ 102 | FARUM | DK-3520 | |
| K092951 | MECTRON S.P.A. |
15, VIA LORETO | CARASCO | 16042 | |
| K993223 | MEDIPHOTONIX, LC |
484 H ST. | SALT LAKE CITY | UT | 84103 |
| K060646 | MONITEX INDUSTRIAL CO., LTD. |
NO. 58, FU-CHIUN STREET | HSIN CHU CITY | 30067 | |
| K051203 | MONITEX INDUSTRIAL CO., LTD. |
6F, 70 GUANG-FU RD., SEC 1, | TAIPEI | 241-58 | |
| K133040 | MONITEX INDUSTRIAL CO., LTD. |
6F, 70 SEC. 1 GUANG-FU ROAD | NEW TAIPEI CITY | 241 58 | |
| K152192 | MONITEX INDUSTRIAL CO., LTD. |
6F, 70 SEC. 1 GUANG-FU ROAD | NEW TAIPEI CITY | 241-58 | |
| K080035 | MONITEX INDUSTRIAL CO., LTD. |
6F, 70 SEC. 1 GUANG-FU ROAD | SAN-CHUNG CITY | 241-58 | |
| K150205 | MONITEX INDUSTRIAL CO., LTD. |
6F, 70 SEC. 1 GUANG-FU ROAD, SANCHONG DIST. | NEW TAIPEI CITY | 241-58 | |
| K161855 | MONITEX INDUSTRIAL CO., LTD. |
6F, 70 SEC. 1 GUANG-FU ROAD, SANCHONG DIST. | NEW TAIPEI CITY | 241-58 | |
| K153078 | MONITEX INDUSTRIAL CO., LTD. |
6F, 70 SEC. 1 GUANG-FU ROAD | NEW TAIPEI CITY | 241-58 | |
| K091887 | MONITEX INDUSTRIAL CO., LTD. |
6F, 70 SEC. 1 GUANG-FU ROAD | SAN-CHUNG CITY | 241-58 | |
| K152936 | NATIONAL DENTAL INC. |
3-149 COLLIER ST. | BARRIE | L4M 1H6 | |
| K043302 | NOVA RANGER, INC. |
16787 BERNARDO CENTER DRIVE | SAN DIEGO | CA | 92128 |
| K000393 | NOVA/DA VINCI SYSTEMS, INC. |
9885 MESA RIM | SAN DIEGO | CA | 92121 |
| K063003 | PARKELL, INC. |
300 EXECUTIVE DR. | EDGEWOOD | NY | 11717 |
| K061695 | PENG LIM ENTERPRISE CO., LTD. |
67 HWA RONG RD., 2ND FL., | KAOHSIUNG | ||
| K052349 | PENTRON CLINICAL TECHNOLOGIES |
68-70 NORTH PLAINS INDUSTRIAL | WALLINGFORD | CT | 06492 |
| K153514 | PREMIUM PLUS INTERNATIONAL LIMITED |
FLAT 1001 YUEN LONG TRADING CENTRE, 33 WANG YIP STREET WEST | HONG KONG | ||
| K172426 | Promident LLC |
618 Corporate Way Unit 1 | Valley Cottage | NY | 10989 |
| K023652 | REMEDENT NV |
20992 BAKE PKWY. | LAKE FOREST | CA | 92692 |
| K020884 | ROLENCE ENT. INC. |
18-3 LANE 231 PU CHUNG RD. | CHUNGLI | 320 | |
| K020877 | ROLENCE ENT. INC. |
18-3 LANE 231 PU CHUNG RD. | CHUNGLI | 320 | |
| K023545 | ROLENCE ENT. INC. |
18-3 LANE 231 PU CHUNG RD. | CHUNGLI | 320 | |
| K020874 | ROLENCE ENT. INC. |
18-3 LANE 231 PU CHUNG RD. | CHUNGLI | 320 | |
| K960364 | ROLENCE ENTERPRISE CO. LTD. |
226 KONG-SHIEH-SIR VILLAGE | CHUNGLI, TAIWAN R.O.C. | ||
| K991863 | ROLENCE ENTERPRISE CO. LTD. |
18-3 LANE 231 PU CHUNG RD. | CHUNGLI | ||
| K991865 | ROLENCE ENTERPRISE CO. LTD. |
18-3 LANE 231 PU CHUNG RD. | CHUNGLI | ||
| K960351 | ROLENCE ENTERPRISE CO. LTD. |
226 KONG-SHIEH-SIR VILLAGE | CHUNGLI, TAIWAN R.O.C. | ||
| K001719 | ROLENCE ENTERPRISE CO. LTD. |
18-3 LANE 231 PU CHUNG RD. | CHUNGLI 320 | ||
| K030811 | SAMM, INC. |
11661 SAN VICENTE BLVD. | LOS ANGELES | CA | 90049 |
| K961735 | SATELEC |
70 WALNUT ST. | WELLESLEY | MA | 02481 |
| K040808 | SATELEC |
70 WALNUT ST. | WELLESLEY | MA | 02481 |
| K032465 | SATELEC |
70 WALNUT ST. | WELLESLEY | MA | 02481 |
| K072181 | SATELEC |
124 GAITHER DRIVE | MT. LAUREL | NJ | 08054 |
| K131906 | SATELEC-ACTEON GROUP |
124 GAITHER DRIVE , SUITE 140 | MT LAUREL | NJ | 08054 |
| K002991 | SOFT-CORE TEXAS, INC. |
5424 RUFE SNOW DR., #102 | NORTH RICHLAND HILLS | TX | 76180 |
| K030568 | SOUTHERN DENTAL INDUSTRIES, INC. |
729 N. ROUTE 83, SUITE 315 | BENSENVILLE | IL | 60106 |
| K992728 | SPRING HEALTH PRODUCTS, INC. |
705 GENERAL WASHINGTON AVE. | NORRISTOWN | PA | 19403 |
| K022265 | SVENSKA DENTAL INSTRUMENTS AB |
PO BOX 723 | UPPLANDS VAESBY | 194 27 | |
| K063116 | SYBRON DENTAL SPECIALTIES |
100 BAYVIEW CIRCLE | NEWPORT BEACH | CA | 92660-8915 |
| K021797 | SYBRON DENTAL SPECIALTIES, INC. |
1717 WEST COLLINS AVE. | ORANGE | CA | 92867 |
| K020267 | SYBRON DENTAL SPECIALTIES, INC. |
1717 WEST COLLINS AVE. | ORANGE | CA | 92667 |
| K021374 | TOEI ELECTRIC CO., LTD. |
55 Northern Blvd. | Great Neck | NY | 11021 |
| K210550 | Ultradent Products, Inc |
505 West Ultradent Drive (10200 South) | South Jordan | UT | 84095 |
| K003383 | ULTRADENT PRODUCTS, INC. |
505 WEST 10200 SOUTH | SOUTH JORDAN | UT | 84095 |
| K110582 | ULTRADENT PRODUCTS, INC. |
505 WEST 10200 SOUTH | SOUTH JORDAN | UT | 84095 |
| K160551 | ULTRADENT PRODUCTS, INC. |
505 WEST 10200 SOUTH | SOUTH JORDAN | UT | 84095 |
| K190627 | Ultradent Products, Inc. |
505 West Ultradent Drive (10200 South) | South Jordan | UT | 84095 |
| K220471 | Ultradent Products, Inc. |
505 West Ultradent Drive (10200 South) | South Jordan | UT | 84095 |
| K083647 | ULTRADENT PRODUCTS, INC. |
505 WEST 10200 SOUTH | SOUTH JORDAN | UT | 84095 |
| K153018 | VOCO GMBH |
Anto-Flettner-Str. 1-3 | Cuxhaven | 27472 |
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