FDA 510(k) Applications for Medical Device:
Unit, Operative Dental
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K000968 | A-DEC, INC. |
2601 CRESTVIEW DR. | NEWBERG | OR | 97132-9257 |
| K000966 | A-DEC, INC. |
2601 CRESTVIEW DR. | NEWBERG | OR | 97132-9257 |
| K000967 | A-DEC, INC. |
2601 CRESTVIEW DR. | NEWBERG | OR | 97132-9257 |
| K102234 | A-DEC, INC. |
2601 CRESTVIEW DR. | NEWBERG | OR | 97132-9257 |
| K213932 | A-dec, Inc. |
2601 Crestview Drive | Newberg | OR | 97132 |
| K082985 | A-DEC, INC. |
2601 CRESTVIEW DR. | NEWBERG | OR | 97132-9257 |
| K032756 | A-DEC, INC. |
2601 CRESTVIEW DR. | NEWBERG | OR | 97132-9257 |
| K960506 | A-DEC, INC. |
2601 CRESTVIEW DR. | NEWBERG | OR | 97132-9257 |
| K051657 | A-DEC, INC. |
2601 CRESTVIEW DR. | NEWBERG | OR | 97132-9257 |
| K962665 | A-DEC, INC. |
2601 CRESTVIEW DR. | NEWBERG | OR | 97132-9257 |
| K032757 | A-DEC, INC. |
2601 CRESTVIEW DR. | NEWBERG | OR | 97132-9257 |
| K032070 | A-DEC, INC. |
2601 CRESTVIEW DR. | NEWBERG | OR | 97132-9257 |
| K183121 | AIOBIO Co., Ltd. |
#306. Sunil Technopia 555, Dunchon-dacro, Jungwon-gu | Seongnam-si | 13215 | |
| K984584 | AIR TECHNIQUES, INC. |
70 CANTIAGUE ROCK RD. | HICKSVILLE | NY | 11802 |
| K974204 | AIR TECHNIQUES, INC. |
70 CANTIAGUE ROCK RD. | HICKSVILLE | NY | 11802 |
| K964271 | AIREL-WEST |
2550 M STREET, N.W. | WASHINGTON | DC | 20037 |
| K012213 | AMERICAN DENTAL TECHNOLOGIES, INC. |
5555 BEAR LN. | CORPUS CHRISTI | TX | 78405 |
| K023815 | ANODIA SYSTEMS |
514 SOUTH THIRD ST. | DANVILLE | KY | 40422 |
| K023896 | ANODIA SYSTEMS |
514 SOUTH THIRD ST. | DANVILLE | KY | 40422 |
| K023213 | ANODIA SYSTEMS |
514 SOUTH THIRD ST. | DANVILLE | KY | 40422 |
| K981144 | AQUARIUS TECHNOLOGIES, INC. |
1822 SUNSET PL. | LONGMONT | CO | 80501 |
| K040117 | ARROW INDUSTRIES LLC |
530 5TH STREET | NECHE | ND | 58265-4033 |
| K050201 | ASEPTICO, INC. |
8333 216TH ST., S.E. | WOODINVILLE | WA | 98072 |
| K022217 | ASEPTICO, INC. |
8333 216TH ST., S.E. | WOODINVILLE | WA | 98072 |
| K101332 | ASEPTICO, INC. |
8333 216TH ST., S.E. | WOODINVILLE | WA | 98072 |
| K974487 | ASI MEDICAL, INC. |
14550 EAST EASTER AVE. | ENGLEWOOD | CO | 80112 |
| K110481 | ASI MEDICAL, INC. |
14550 E EASTER AVE. | CENTENNIAL | CO | 80112 |
| K971100 | ATRION MEDICAL PRODUCTS, INC. |
1426 CURT FRANCIS RD. | ARAB | AL | 35016 |
| K011222 | BELL DENTAL PRODUCTS, LLC. |
3003 ARAPAHOE ST., #101-B | DENVER | CO | 80205 |
| K000799 | BELMONT EQUIPMENT CORP. |
101 BELMONT DR. | SOMERSET | NJ | 08873-1204 |
| K983661 | BELMONT EQUIPMENT CORP. |
101 BELMONT DR. | SOMERSET | NJ | 08873-1204 |
| K042759 | BIEN-AIR SA SWITZERLAND |
LANGASSE 60, CASE POSTALE | BIENNE 6 | CH-2500 | |
| K980049 | BLADHS PLAST AB |
59 SWIFTWATER RD. | POCONO MANOR | PA | 18349 |
| K020833 | BOYD INDUSTRIES, INC. |
12900 44TH ST. NORTH | CLEARWATER | FL | 33762 |
| K063646 | CAMSIGHT CO., INC. |
3380 SAN FERNADO ROAD | LOS ANGELES | CA | 90065 |
| K983739 | CAMSIGHT, INC. |
11661 SAN VICENTE BLVD. | LOS ANGELES | CA | 90049 |
| K091186 | CARESTREAM HEALTH, INC. |
1765 THE EXCHANGE | ATLANTA | GA | 30339 |
| K112321 | CARESTREAM HEALTH,INC. |
1765 THE EXCHANGE | ATLANTA | GA | 30339 |
| K023513 | CASTELLINI S.P.A. |
VIA SALICETO 22 | CASTEL MAGGIORE, BOLOGNA | 40013 | |
| K000837 | CASTELLINI S.P.A. |
VIA SALICETO 22 | CASTEL MAGGIORE, BOLOGNA | 40013 | |
| K133412 | CEFLA S.C. |
110 E. GRANADA BLVD. SUITE 207 | ORMOND BEACH | FL | 32176 |
| K092917 | CEFLA S.C. |
110 E. GRANADA BLVD. | ORMOND BEACH | FL | 32176 |
| K062897 | CEFLA S.C.R.L. |
110 E GRANADA BLVD. | ORMOND BEACH | FL | 32176 |
| K013690 | CONFIDENT TECHNOLOGY, INC. |
13841 ROSWELL AVE. # K | CHINO | CA | 91710 |
| K081237 | CRAFTMASTER CONTOUR EQUIPMENT, INC. |
1705 S. CAPITAL OF TEXAS HWY | AUSTIN | TX | 78746 |
| K041458 | DENIMED ELECTRONICA S.H. |
1460 NW 107 AVE. | MIAMI | FL | 33172 |
| K020206 | DENT CORP. RESEARCH & DEVELOPMENT |
7-11 S. BROADWAY | WHITE PLAINS | NY | 10601 |
| K033925 | DENTAL COMPONENTS, INC. |
305 NORTH SPRINGBROOK RD. | NEWBERG | OR | 97132-0228 |
| K971727 | DENTAL COMPONENTS, INC. |
305 NORTH SPRINGBROOK RD. | NEWBERG | OR | 97132-0228 |
| K980474 | DENTAL/MEDICAL DIAGNOSTIC SYSTEMS, INC. |
3722 AVE. SAUSALITO | IRVINE | CA | 92606 |
| K990844 | DENTALEZ GROUP |
1816 COLONIAL VILLAGE LN. | LANCASTER | PA | 17601 |
| K964942 | DENTALPURE CORP. |
300 SOUTH OWASSON BLVD. | ST. PAUL | MN | 55117 |
| K973492 | DENTALVIEW, INC. |
15540-D ROCKFIELD BLVD. | IRVINE | CA | 92618 |
| K982480 | DENTALVIEW, INC. |
15540-D ROCKFIELD BLVD. | IRVINE | CA | 92618 |
| K032904 | DENTSPLY INTL. |
901 W. OAKTON ST. | DES PLAINES | IL | 60018 |
| K000112 | DENTSPLY INTL. |
901 WEST OAKTON ST. | DES PLAINES | IL | 60018-1884 |
| K981663 | DIGITAL DOC LLC |
11661 SAN VICENTE BLVD. | LOS ANGELES | CA | 90049 |
| K130534 | DIPLOMAT DENTAL S.R.O. |
816 CONGRESS AVENUE, SUITE 1400 | AUSTIN | TX | 78701 |
| K040116 | DXM CO., LTD. |
55 Northern Blvd. | Great Neck | NY | 11021 |
| K991098 | ELECTRO-OPTICAL SCIENCES, INC. |
5 WHITCOMB AVE. | AYER | MA | 01432 |
| K983285 | ENGLE DENTAL SYSTEMS |
4115 24TH AVE SUITE A | FOREST GROVE | OR | 97116 |
| K132315 | ERGONOMIC PRODUCTS, INC. |
240 ANNETTE AVE | WOONSOCKET | RI | 02895 |
| K050571 | EURODENT S.P.A. |
79 HUDSON STREET | HOBOKEN | NJ | 07030 |
| K991011 | FIBERDENT CORP. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K173608 | Forest Dental Products, Inc. |
6200 NE Cherry Drive | Hillsboro | OR | 97124 |
| K103550 | FOSHAM YOBOSHI MEDICAL EQUIPMENT CO., LTD |
ROOM 2706, BLOCK A, ZHONGFANG | SHENZHEN, GUANGDONG | 528500 | |
| K983847 | GERMIPHENE CORP. |
1379 COLBORNE ST., EAST | BRANTFORD, ONT | N3T 5V7 | |
| K964796 | GERMIPHENE CORP. |
1379 COLBORNE ST., EAST | BRANTFORD, ONT | N3T 5V7 | |
| K092851 | GLOBAL DENTAL DIRECT, INC. |
2120 PARAMOUNT CRESCENT | ABBOTSFORD, BC | V2T-6A5 | |
| K102223 | HALLIM DENTECH CO., LTD. |
951 STARBUCK ST. UNIT J | FULLERTON | CA | 92833 |
| K150490 | Heka Dental A/S |
Balsershoj 38 | DK-2635 Ishoj | ||
| K070196 | HR DENTAL PRODUCTS INC |
21 KENVIEW BLVD, UNIT 9 | BRAMPTON, ONTARIO | L6T 5G7 | |
| K990479 | HYGENITEK, INC. |
7370 WOODBINE AVE. | MARKHAM, ONTARIO | L3R1A5 | |
| K970626 | I.C.S. |
10054 MESA RIDGE COURT | SAN DIEGO | CA | 92121 |
| K973035 | INNOVATIVE MEDICAL SYSTEMS, INC. |
55 STEAM WHISTLE DR. | IVYLAND | PA | 18974 |
| K981534 | INTEGRA MEDICAL |
11661 SAN VICENTE BLVD. | LOS ANGELES | CA | 90949 |
| K972019 | INTERNATIONAL IMAGING ELECTRONICS |
881 REMINGTON BLVD. | BOLINGBROOK | IL | 60440-4932 |
| K984332 | INTERNATIONAL TECHNOLOGY CONCEPTS |
6114 LASALLE AVE. | OAKLAND | CA | 94611 |
| K043496 | J. MORITA USA, INC. |
1425 K ST. N.W. | WASHINGTON | DC | 20005 |
| K052574 | J.O. SUAREZ & CIA, LTDA |
RUA SABURO SUMIYA, NO 241 | ALDEINHA, BARUERI, SP | 06440-110 | |
| K001445 | JULIE ALLIANCE |
110 EAST GRANADA BLVD. | ORMOND BEACH | FL | 32175-0036 |
| K161488 | KALTENBACH & VOIGT GMBH |
BISMARCKRING 39 | BIBERACH | 88400 | |
| K080677 | KALTENBACH & VOIGT GMBH & CO. |
1717 WEST COLLINS | ORANGE | CA | 92867 |
| K982658 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K991161 | KAY SEE DENTAL MFG. CO. |
124 EAST MISSOURI AVE. | KANSAS CITY | MO | 64106-1294 |
| K220873 | Lares Research |
295 Lockheed Ave | Chico | CA | 95973 |
| K984609 | LITE SPECIALTY METAL WORKS, INC. |
20460 S.W. AVERY CT. | TUALATIN | OR | 97062 |
| K021083 | LUMALITE, INC. |
11661 SAN VICENTE BLVD. | LOS ANGELES | CA | 90049 |
| K962527 | MEDCARE MEDICAL GROUP, INC. |
234 OLD HOMESTEAD HWY. | EAST SWANZEY | NH | 03446 |
| K974542 | MEDICAL DYNAMICS, INC. |
99 INVERNESS DR., EAST | ENGLEWOOD | CO | 80112 |
| K211556 | MegaGen Implant Co., Ltd. |
45, Secheon-ro,7-gil | Daegu | 42921 | |
| K202963 | Mgnewton Ltd. |
472, Hanjanggun-ro, Jain-myeon | Gyeongsan-si | 38552 | |
| K012744 | MHT OPTIC RESEARCH AG |
MANDACHSTR. 50 | NIEDERHASLI | CH-8155 | |
| K970002 | MICRO MOTORS, INC. |
151 EAST COLUMBINE AVE. | SANTA ANA | CA | 92707 |
| K973765 | MICRYLIUM LABORATORIES |
1755 WEST UNIVERSITY DR. | TEMPLE | AZ | 85281 |
| K120239 | MIDMARK |
1801 EDGECLIFF DRIVE | FULLERTON | CA | 92831 |
| K003090 | MIDMARK CORP. |
OUTE 47 WEST, VISTA DR. | VERSAILLES | OH | 45380 |
| K041805 | MIRAS MIRROR IMAGING SOLUTIONS, LTD. |
11 MENACHEM BEGIN STREET | RAMAT-GAN | ||
| K963548 | MRLB INTL., INC. |
305 DEMERS, | EAST GRAND FORKS | MN | 56721 |
| K992893 | MRLB INTL., INC. |
2450 COLLEGE WAY | FERGUS FALLS | MN | 56537 |
| K992868 | MRLB INTL., INC. |
2450 COLLEGE WAY | FERGUS FALLS | MN | 56537 |
| K080438 | NORTH WEST MEDICAL INSTRUMENT (GROUP) CO., LTD. |
# 19, LANE 999 ZHONGSHAN 2 RD | SHANGHAI | 200030 | |
| K213742 | Olsen Ind·stria e ComΘrcio S.A. |
Av. Ivo Luchi, 68 | Palhoτa | 88133-510 | |
| K180935 | Olsen Industria e Comercio S.A. |
Av. Ivo Luchi, 68 - Jardim Eldorado | Palhoτa - | 88133-510 | |
| K002620 | ORA METRIX, INC. |
12740 HILLCREST ROAD, STE 100 | DALLAS | TX | 75230 |
| K183347 | Osstem Implant Co., Ltd. |
1st Floor, B-dong, 135 Gasan Digital 2-ro, Geumcheon-gu | Seoul | 08504 | |
| K152830 | OSSTEM IMPLANT CO.,LTD. |
1ST FLOOR, B-DONG, 135 GASAN DIGITAL 2-RO, GEUMCHEON-GU | SEOUL | 153-759 | |
| K983735 | PALL MEDICAL |
2200 NORTHERN BLVD. | EAST HILLS | NY | 11548-1209 |
| K983731 | PALL MEDICAL |
2200 NORTHERN BLVD. | EAST HILLS | NY | 11548-1209 |
| K171872 | Pelton & Crane |
11727 Fruehauf Drive | Charlotte | NC | 28273 |
| K143696 | PELTON & CRANE |
11727 FRUEHAUF DR. | CHARLOTTE | NC | 28273 |
| K962071 | PELTON & CRANE CO. |
11727 FRUEHAUF DR. | CHARLOTTE | NC | 28243 |
| K972033 | PLANMECA OY |
ASENTAJANKATU 6 | HELSINKI | 00880 | |
| K984013 | PLANMECA OY |
ASENTAJANKATU 6 | HELSINKI | 00880 | |
| K961420 | PLANMECA OY |
ASENTAJANKATU 6 | HELSINKI | 00880 | |
| K081699 | PLANMECA USA, INC. |
100 N. GARY AVE. SUITE A | ROSELLE | IL | 60172 |
| K954471 | POWERS DENTAL & MEDICAL TECHNOLOGY, INC. |
1855 WALDORF N.W. | GRAND RAPIDS | MI | 49544 |
| K132245 | PRO DENTAL SERVICES LLC. |
1121 PLAYER WAY | HERNDON | VA | 20170 |
| K090079 | PROGENY, INC. |
675 HEATHROW DRIVE | LINCOLNSHIRE | IL | 60069 |
| K980106 | PROMA, INC. |
751 EAST KINGSHILL PL. | CARSON | CA | 90746-1223 |
| K971278 | PURE CO. |
2045 PREISKER LN. | SANTA MARIA | CA | 93454 |
| K161734 | RITTER CONCEPT GMBH |
BAHNHOFSTRABE 65 | ZWONITZ | 208297 | |
| K043325 | ROLENCE ENTEPRISE, INC. |
18-3, LANE 231 | CHUNGI | 320 | |
| K100212 | SAFARI DENTAL, INC. |
94 D ENTERPRISES BOUL. | BOISBRIAND, QUEBEC | J7G 2T3 | |
| K040529 | SATELEC |
70 WALNUT ST. | WELLESLEY | MA | 02481 |
| K963778 | SCHICK TECHNOLOGIES, INC. |
31-00 47TH AVE. | LONG ISLAND | NY | 11101 |
| K984641 | SCHOELLY FIBEROPTIC, GMBH |
45 PONTIAC RD. | NEWTON | MA | 02248 |
| K984556 | SCHOLLY FIBEROPTIC GMBH |
ROBERT-BOSCH-STR. 1-3 | DENZLINGEN | D-79211 | |
| K960556 | SCITECH SOLUTIONS, INC. |
562 1ST AVENUE SOUTH #700 | SEATTTLE | WA | 98104 |
| K973996 | SCITECH SOLUTIONS, INC. |
562 1ST AVENUE SOUTH #700 | SEATTTLE | WA | 98104 |
| K982009 | SCITECH SOLUTIONS, INC. |
562 1ST AVENUE SOUTH #700 | SEATTTLE | WA | 98104 |
| K964619 | SDS DENTAL, INC. |
5101 N.W. 21ST AVE. N.W. | FORT LAUDERDALE | FL | 33309 |
| K063302 | SHANGHAI DENTAL INSTRUMENT FACTORY |
REGULATORY TECHNOLOGY SERVICES | BUFFALO | MN | 55313 |
| K111907 | SHANGHAI DYNAMIC INDUSTRY CO., LTD. |
RM 1706, NO. 128 SONGLE RD | SHANGHAI | 201600 | |
| K052470 | SHANGHAI FIMET MEDICAL INSTRUMENT CO., LTD. |
P.O. BOX 7007 | DEERFIELD | IL | 60015 |
| K213749 | Shinhung Company Ltd |
Shinhung Bldg, 450 Cheongpa-ro, Jung-gu | Seoul | 100-858 | |
| K151996 | SHINHUNG COMPANY LTD |
SHINHUNG BLDG, 450 CHEONGPA-RO, JUNG-GU | SEOUL | 100-858 | |
| K150909 | Sirona Dental Systems GMBH |
Fabrikstrasse 31 | Bensheim | 64625 | |
| K983242 | SIRONA DENTAL SYSTEMS GMBH |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760-4153 |
| K032543 | SIRONA DENTAL SYSTEMS GMBH |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760-4153 |
| K151045 | SIRONA DENTAL SYSTEMS GMBH |
FABRIKSTRASSE 31 | BENSHEIM | 64625 | |
| K980577 | SODEXCO |
1450 W. 8040 S. | SANDY | UT | 84088 |
| K983625 | SOPRO |
PLACE ST. CHRISTOPHE | MARSEILLE | 13011 | |
| K990948 | SOPRO |
PLACE ST. CHRISTOPHE | MARSEILLE | 13011 | |
| K012505 | SOPRO |
PLACE ST. CHRISTOPHE | MARSEILLE | F-13011 | |
| K061175 | SOTA PRECISION OPTICS, INC. |
845 ARONSON LAKE COURT | ROSWELL | GA | 30075 |
| K032341 | SOTA PRECISION OPTICS, INC. |
1308 MORNINGSIDE PARK DR. | ALPHARETTA | GA | 30022 |
| K991946 | STERILEX CORP. |
7-I GWYNNS HILL COURT | OWINS MILLS | MD | 21117 |
| K031681 | STERISIL |
200 S. WILCOX | CASTLE ROCK | CO | 80104 |
| K000941 | STERLTECH, INC. |
60 LAKESIDE BLVD. WEST | WATERBURY | CT | 06708 |
| K991035 | SYBRON DENTAL SPECIALTIES, INC. |
1717 WEST COLLINS AVE. | ORANGE | CA | 92867 |
| K992195 | SYBRON DENTAL SPECIALTIES, INC. |
1717 WEST COLLINS AVE. | ORANGE | CA | 92867 |
| K982117 | T.A. COLEMAN ENT. |
601 13TH STREET, N.W. | WASHINGTON | DC | 20005 |
| K152100 | TAKARA BELMONT CORPORATION |
1-1-2 CHOME, | OSAKA | 542-0083 | |
| K003265 | TEXAS INSTITUTE FOR CONSERVATIVE DENTISTRY |
702 OSAGE ST. | REFUGIO | TX | 78377 |
| K000577 | THE YOSHIDA DENTAL MFG. CO., LTD. |
1-3-6, KOTOBASHI, SUMIDA-KU | TOKYO | 130 8516 | |
| K981171 | THERATECHNOLOGIES, INC. |
630,BOUL. RENE-LEVESQUE QUEST | MONTREAL QUEBEC | H3B 1S6 | |
| K141504 | THEROZONE USA, INC. |
2701 OCEAN PARK BLVD, SUITE 108 | SANTA MONICA | CA | 90405 |
| K071485 | TPC ADVANCED TECHNOLOGY, INC. |
18525 EAST GALE AVE. | CITY OF INDUSTRY | CA | 91748 |
| K974238 | TRINITY LABORATORIES, INC. |
201 KILEY DR. | SALISBURY | MD | 21801 |
| K033419 | TROPHY RADIOLOGIE |
4 RUE F. PELLOUTIER | MARNE LA VALLEE CEDEX 2 | 77437 | |
| K001541 | VIDEO DENTAL CONCEPTS, INC. |
110 EAST GRANADA BLVD. | ORMOND BEACH | FL | 32175-0036 |
| K020957 | VIDEO DENTAL CONCEPTS, INC. |
110 EAST GRANADA BLVD. | ORMOND BEACH | FL | 32175-0036 |
| K973410 | W. EDWARD JOHANSEN |
11661 SAN VICENTE BLVD. | LOS ANGELES | CA | 90049 |
| K981565 | WAGGONER PRODUCT DEVELOPMENT |
7517 WHITE CASTLE LN. | PLANO | TX | 75025 |
| K961409 | WATER SOLUTION TECHNOLOGIES |
945 BEGONIA COURT | CARLSBAD | CA | 92009 |
| K001878 | WATERCLAVE, L.L.C. |
8045 BIG BEND BLVD., SUITE 203 | WEBSTER GROVES | MO | 63119-2714 |
| K981937 | WELCH ALLYN, INC. |
4619 JORDAN RD. | SKANEATELES FALLS | NY | 13153-0187 |
| K082294 | WESTAR MEDICAL PRODUCTS, INC. |
4470 CHENNAULT BEACH RD | MUKILTEO | WA | 98275 |
| K040691 | WIN-US TECHNOLOGY CO., LTD. |
1308 MORNINGSIDE PARK DRIVE | ALPHARETTA | GA | 30022 |
| K130410 | XIANYANG NORTH WEST MEDICAL INSTRUMENT (GROUP) CO. |
P.O. BOX 237-023 | SHANGHAI | 200237 | |
| K142206 | Zhuhai Siger Medical Equipment Co., Ltd |
Building 2, No.1 Chuangxin Yi Road, Tangjiawan Town | Zhuhai | 519000 |
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