FDA 510(k) Applications for Medical Device:
Handpiece, Air-Powered, Dental

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K073284 (EMS SA) ELECTRO MEDICAL SYSTEMS 49 PLAIN ST.
NORTH ATTLEBORO MA 02760
K082716 A-DEC, INC. 2601 CRESTVIEW DR.
NEWBERG OR 97132-9257
K082827 A-DEC, INC. 2601 CRESTVIEW DR.
NEWBERG OR 97132-9257
K070663 A-DEC, INC. 2601 CRESTVIEW DR.
NEWBERG OR 97132-9257
K993526 A-DEC, INC. 2601 CRESTVIEW DR.
NEWBERG OR 97132-9257
K992011 A-DEC, INC. 2601 CRESTVIEW DR.
NEWBERG OR 97132-9257
K010127 A-DEC, INC. 2601 CRESTVIEW DR.
NEWBERG OR 97132-9257
K991401 ADVANCED TECHNOLOGY RESEARCH (A.T.R.) S.R.P. 21911 ERIE LN.
LAKE FOREST CA 92630
K000547 ADVANCED TECHNOLOGY RESEARCH (A.T.R.) S.R.P. VIA DEL PESCINO, 6
PISTOIA 51100
K101717 AEROBINE, INC 7670 OPPORTUNITY ROAD
SAN DIEGO CA 92111
K974670 ATHENA TECHNOLOGY, INC. 984 NORTH AMELIA AVE.
SAN DIMAS CA 91773
K974671 ATHENA TECHNOLOGY, INC. 984 NORTH AMELIA AVE.
SAN DIMAS CA 91773
K072754 AXENIC DENTAL, INC. 259 EAST MICHIGAN AVE.
KALAMAZOO MI 49007
K172543 Beijing Dongbo Dental Handpiece Co., Ltd. Room 201, Building 4, No.9 Anqing Street
Beijing 101318
K202371 Beijing Dongbo Dental Handpiece Co., Ltd. 3F, Building 3, No. 17, First Jinmayuan Street,
Beijing 101318
K071561 BEIJING NORTH POLE DENTAL HANDPIECE CO., LTD SUITE 8D, NO, 19 LANE 999,
SHANGHAI 200030
K031851 BETHEL, INC 320 S. VINE AVENUE
TYLER TX 75702
K112623 BEYES DENTAL CANADA INC 3500 SOUTH DUPONT HIGHWAY
DOVER DE 19901
K112869 BEYES DENTAL CANADA INC 3500 SOUTH DUPONT HIGHWAY
DOVER DE 19901
K983183 BIEN AIR USA, INC. 19600 FAIRCHILD RD. SUITE 250
IRVINE CA 92612
K984244 BIEN AIR USA, INC. 18140 SMOKESIGNAL DR.
SAN DIEGO CA 92127
K980585 BIOLASE TECHNOLOGY, INC. 981 CALLE AMANECER
SAN CLEMENTE CA 92673
K000834 CASTELLINI S.P.A. VIA SALICETO 22
CASTEL MAGGIORE, BOLOGNA 40013
K033213 CODENT TECHNICAL INDUSTRY CO., LTD. NO.58, FU-CHUIN STREET
HSIN-CHU CITY ROC
K133069 CODENT TECHNICAL INDUSTRY CO., LTD. 5F., No.90, Luke 5th Rd., Luzhu District
Kaohsiung City 82151
K150798 CODENT TECHNICAL INDUSTRY CO., LTD. 5F., No.90, Luke 5th Rd., Luzhu District
Kaohsiung City 82151
K152146 CODENT TECHNICAL INDUSTRY CO., LTD. 5F., No.90, Luke 5th Rd., Luzhu District
Kaohsiung City 82151
K981990 D.B.I. AMERICA CORP. 8194 WOODLAND CENTER BLVD.
TAMPA FL 33614
K101551 DELMA MEDICAL INSTRUMENT (GUANGZHOU) CO., LTD. 3500 SOUTH DUPONT HIGHWAY
DOVER DE 19901
K070297 DENTAL AIR SOLUTIONS OF NC, INC. 224 BRANCHSIDE LANE
HOLLY SPRINGS NC 27540
K960352 DENTAL DISPOSABLES INTL., INC. 15 SOUTH MAIN ST.
MARLBORO NJ 07746
K160410 Dental Savings Club 31 Serge Garant
Montreal h3E 0A6
K982593 DENTALEZ GROUP 1816 COLONIAL VILLAGE LN.
LANCASTER PA 17601
K130455 DENTALEZ GROUP, STARDENTAL DIVISION 1816 COLONIAL VILLAGE LN.
LANCASTER PA 17601
K153411 DENTALEZ, INC. 1816 COLONIAL VILLAGE LANE
LANCASTER PA 17601
K113301 DENTALEZ, INC. 1816 COLONIAL VILLAGE LN.
LANCASTER PA 17601
K173465 DentalEZ, Inc. 1816 Colonial Village Lane
Lancaster PA 17601
K070869 DENTALEZ, INC. 1816 COLONIAL VILLAGE LN.
LANCASTER PA 17601
K192412 DentalEZ, Inc. 1816 Colonial Village Lane
Lancaster PA 17601
K093072 DENTALEZ, INC. 1816 COLONIAL VILLAGE LN.
LANCASTER PA 17601
K053368 DENTSPLY INTERNATIONAL 221 W. PHILADELPHIA ST.
YORK PA 17404
K041141 DENTSPLY INTL. 221 WEST PHILADELPHIA STREET
YORK PA 17404
K031145 DENTSPLY INTL. 570 WEST COLLEGE AVE.
YORK PA 17405-0872
K003518 DENTSPLY INTL. 570 WEST COLLEGE AVE.
YORK PA 17405-0872
K012720 DENTSPLY INTL. 570 WEST COLLEGE AVE.
YORK PA 17405-0872
K072989 DENTSPLY INTL., INC. SUSQUEHANNA COMMERCE CENTER
YORK PA 17404
K192409 Dentsply Sirona 221 W Philadelphia Street, Suite 60W
York PA 17401
K970104 DW INDUSTRIES, INC. 601 13TH ST. N.W.
WASHINGTON DC 20005
K132478 E.M.S. ELECTRO MEDICAL SYSTEMS S.A. 62 FOREST ST., STE 300
MARLBOROUGH MA 01752
K132480 E.M.S. ELECTRO MEDICAL SYSTEMS S.A. 62 FOREST ST., STE 300
MARLBOROUGH MA 01752
K151912 E.M.S. ELECTRO MEDICAL SYSTEMS S.A. Rte de Champ-Colin 2
Nyon CH-1260
K082791 E.M.S. ELECTRO MEDICAL SYSTEMS S.A. 49 PLAIN ST
NORTH ATTLEBORO MA 02760
K171174 E.M.S. Electro Medical Systems S.A. 31 CH. de la Vuarpilliere
Nyon ch-1260
K022119 ELECTRO MEDICAL SYSTEMS SA 49 PLAIN ST.
NORTH ATTLEBORO MA 02760
K991857 ELECTRO MEDICAL SYSTEMS, INC. 49 PLAIN ST.
NORTH ATTLEBORO MA 02760
K092289 EMS ELECTRO MEDICAL SYSTEMS SA 49 PLAIN ST.
NORTH ATTLEBORO MA 02760
K963664 FILMTECH, INC. 581 MCDONALD AVE.
BROOKLYN NY 11218
K181900 Foshan CICADA Dental Instrument Co., Ltd. B5-2F, Guangdong New Light Source Industrial Base
Foshan 528247
K220179 Foshan COXO Medical Instrument Co., Ltd. BLDG 4,District A Guangdong New Light Source Industrial
Foshan 528226
K241074 Foshan SOCO Precision Instrument Co.,Ltd. 3-5 FL. Bldg 4, District A and 5 FL. Bldg 3, District A
Foshan 528226
K181691 Foshan Wenjian Medical Instrument Co., Ltd. Third Floor, No. 3, Jiebian Industrial Zone, LuoCun
Foshan 528225
K972376 GLENWOOD, LLC. 82 NORTH SUMMIT ST.
TENAFLY NJ 07670
K972375 GLENWOOD, LLC. ONE NEW ENGLAND AVE.
PISCATAWAY NJ 08855
K240337 Guangdong JINME Medical Technology Co., Ltd. Room 301, 401, 501, Block No.3, Wanyang Science Park,
Foshan 528200
K170229 GUANGDONG JINME MEDICAL TECHNOLOGY CO., LTD. A15, NEW LIGHT SOURCE INDUSTRIL BASE
FOSHAN 528000
K170236 Guangdong JINME Medical Technology Co., Ltd. A15, New Light Source Industrial Base, Nanhai District
Foshan 528000
K221548 Guilin Woodpecker Medical Instrument Co., Ltd. Information Industrial Park, Guilin National High-Tech Zone
Guilin City 541004
K142063 HANDPIECE CLUB, LLC 62 FOREST STREET, SUITE 300
MARLBOROUGH MA 01752
K100389 HANDPIECE HEADQUARTERS 620 S. PLACENTIA AVE.
PLACENTIA CA 92870
K143183 HANDPIECE HEADQUARTERS 620 S. PLACENTIA AVE.
PLACENTIA CA 92870
K080682 HANDPIECE HEADQUARTERS INC. - HPR INC. 2284 N. GLASSELL ST., UNIT A
ORANGE CA 92865
K113674 HANDPIECE HEADQUARTERS INC. - HPR INC. 620 S. PLACENTIA AVE
PLACENTIA CA 92870
K100731 HARRY J. BOSWORTH CO. 7227 NORTH HAMLIN AVE.
SKOKIE IL 60076
K991492 HARRY J. BOSWORTH CO. 7227 NORTH HAMLIN AVE.
SKOKIE IL 60076
K043497 J. MORITA USA, INC. 1425 K ST. N.W.
WASHINGTON DC 20005
K091065 J. MORITA USA, INC. 1425 K STREET NW
WASHINGTON DC 20005
K190509 J. Morita USA, Inc. 9 Mason
Irvine CA 92618
K070074 J. MORITA USA, INC. 1425 K ST. N.W.
WASHINGTON DC 20005
K043498 J. MORITA USA, INC. 1425 K ST. N.W.
WASHINGTON DC 20005
K041755 J.R. MEDICAL TECHNOLOGIES, INC. 11874 SOUTH EVELYN CIRCLE
HOUSTON TX 77071
K221814 Jaintek Co.,Ltd #302, 419, Byeolmang-ro, Danwon-gu
Ansan-si 15605
K062740 JINDELL MEDICAL INSTRUMENTS CO., LTD. NO. 58, FU-CHIUN ST.
HSIN-CHU CITY 30067
K130560 KALTENBACH & VOIGT GMBH BISMARCKRING 39
BIBERACH / RISS 88400
K181110 Kaltenbach & Voigt GmbH Bismarckring 39
Biberach 88400
K012308 KAVO AMERICA 340 EAST MAIN ST.
LAKE ZURICH IL 60047
K973876 KAVO AMERICA ONE PRUDENTIAL PLAZA,
CHICAGO IL 60601
K031868 KAVO AMERICA PO BOX 7007
DEER FIELD IL 60015
K141576 KAVO DO BRASIL INDUSTRIA E COMERCIO LTDA RUA CHAPECO, 86
SANTA CATARINA
K961163 LARES RESEARCH, INC. 295 LOCKHEED AVE.
CHICO CA 95973
K141221 LARES RESEARCH, INC. 295 LOCKHEED AVE.
CHICO CA 95973
K233122 Litu Tech Ltd. C1-2 No. 12 Denengxi Road Torch Zone, Zhongshan
Guangdong 528437
K963843 MICRO MOTORS, INC. 469 ARROYO DR.
ENCINITAS CA 92024
K961076 MICRO-MEGA SOCIETE ANONYME 5-12 RUE DU TUNNEL
CEDEX BESANCON 25006
K961275 MICRO-MEGA SOCIETE ANONYME 5-12 RUE DU TUNNEL
CEDEX BESANCON 25006
K961235 MICRO-MEGA SOCIETE ANONYME 5-12 RUE DU TUNNEL
CEDEX BESANCON 25006
K133170 MICRON CORP. 1-34-14 HIGASHIYUKIGAYA
OTA-KU, TOKYO 145-0065
K173943 MicroP Technology (Taiwan), Inc. No.40, Junghe Tsuen, Minshiung Township
Chiayi County 621
K202786 MicroP Technology (Taiwan), Inc. No.50, Zhongxiao 2nd St., East Dist, Chiayi City 600, Taiwan
Chiayi City 600
K022535 MICROTECH 3722 AVE. SAUSALITO
IRVINE CA 92606
K962877 MIDWEST DENTAL PRODUCTS CORP. 901 WEST OAKTON ST.
DES PLAINES IL 60018
K955655 MIDWEST DENTAL PRODUCTS CORP. 901 WEST OAKTON ST.
DES PLAINES IL 60018
K963050 MIDWEST DENTAL PRODUCTS CORP. 901 W OAKTON ST.
DES PLAINES IL 60018-1884
K032234 MK-DENT GMBH EISENHUTWEG 15
KUMHAUSEN-PREISENBERG 84036
K051872 MK-DENT GMBH EISENHUTWEG 15
KUMHAUSEN-PREISENBERG 84036
K141886 MODERN KOREA CO., LTD. 2651 E. CHAPMAN AVE. STE 110
FULLERTON CA 92831
K945256 MTC INDUSTRIES AND RESEARCH, LTD. P.O. BOX 232
CARMIEL 20100
K960541 MTI PRECISION PRODUCTS 1129 BLOOMFIELD AVE.
WEST CALDWELL NJ 07006
K070001 MTI PRECISION PRODUCTS 175 OBERLIN AVE., NORTH
LAKEWOOD NJ 08701
K113222 NAKAMURA DENTAL HANDPIECE MFG. CO., LTD. 59-2 MINAMI-CHO
ITABASHI-KU, TOKYO 173-0027
K073652 NAKAMURA MAGNIFIER CO., LTD. 17972 SKY PARK CIRCLE
IRVINE CA 92614
K233308 NAKANISHI INC. 700 Shimohinata
Kanuma 322-8666
K241880 NAKANISHI INC. 700 Shimohinata
Kanuma 322-8666
K203791 NAKANISHI INC. 700 Shimohinata
Kanuma 322-8666
K230888 Nakanishi Inc. 700 Shimohinata
Kanuma 322-8666
K081811 NAKANISHI, INC. 1425 K STREET, N.W.
WASHINGTON DC 20005
K163483 NAKANISHI, INC. 700 Shimohinata
Kanuma-shi 322-8666
K032395 NAKANISHI, INC. 700 SHIMOHINATA
KANUMA-SHI, TOCHIGI-KEN 322-8666
K112673 NAKANISHI, INC. 1201 RICHARDSON DRIVE
RICHARDSON TX 75080
K113655 NAKANISHI, INC. 1201 RICHARDSON DRIVE
RICHARDSON TX 75080
K112024 NAKANISHI, INC. 1201 RICHARDSON DRIVE
RICHARDSON TX 75080
K193264 Ningbo HPDOVE Dental Instruments Co., Ltd. No.588 Xiaolin Road, Xiaolin Town
Cixi City 315321
K093971 NORTH WEST MEDICAL INSTRUMENT (GROUP) CO., LTD. # 19, LANE 999 ZHONGSHAN 2 RD
SHANGHAI 200030
K000710 NOUVAG AG SUDETENSTR. 5
KAUFBEUREN D87600
K954722 NOUVAG AG 555 THIRTEEN ST., N.W.
WASHINGTON DC 20004
K981679 NOUVAG AG SUDETENSTR. 5
KAUFBEUREN D87600
K131014 NSK AMERICA CORP. 1201 RICHARDSON DR.
RICHARDSON TX 75080
K052700 NSK AMERICA CORP. 700-B COOPER CT.
SCHAUMBURG IL 60173
K962542 NSK NAKANISHI, INC. 340 KAMIHINATA,KANUMA-SHI
TOCHIGI-KEN 322
K962543 NSK NAKANISHI, INC. 340 KAMIHINATA,KANUMA-SHI
TOCHIGI-KEN 322
K980162 NSK NAKANISHI, INC. 340 KAMIHINATA,KANUMA-SHI
TOCHIGI-KEN 322
K991701 NSK NAKANISHI, INC. 340 KAMIHINATA,KANUMA-SHI
TOCHIGI-KEN 322
K971774 NSK NAKANISHI, INC. 340 KAMIHINATA,KANUMA-SHI
TOCHIGI-KEN 322
K983168 ORA INNOVATIONS, INC. 319 SW WASHINGTON ST, STE. 620
PORTLAND OR 97204
K000847 ORASYSTEMS 764 SPEEDWELL AVE.
MORRIS PLAINS NJ 07950-2231
K000848 ORASYSTEMS 555 PASSAIC AVE.
WEST CALDWELL NJ 07006
K111249 ORTHOMATICS, INC. 200 WEST COUNTY LINE ROAD #340
HIGHLANDS RANCH CO 80129
K070155 OSSEO SCIENTIFIC, LLC 3138 VEEDER AVE.
TOMS RIVER NJ 08753
K100833 OSSPRAY LTD 3116 N.W. 62ND TERRACE
GAINESVILLE FL 32606
K202674 Pac-Dent, Inc. 670 Endeavor Circle
Brea CA 92821
K952927 PALISADES PHARMACEUTICS, INC. 64 N. SUMMIT ST.
TENAFLY NJ 07670
K120218 PALM BEACH DENTAL SUPPLY D/B/A TEK USA 2700 NE 24TH ST
POMPANO BEACH FL 33069
K982050 PARKELL, INC. 155 SCHMITT BLVD.
FARMINGDALE NY 11735
K971732 PAULINE M. NICHOLLS 321 SOUTH BROAD ST.
MONROE GA 30655
K062947 PENG LIM ENTERPRISE CO., LTD. NO. 58 FU-CHIUN STREET
HSIN-CHU CITY
K954991 PHASE CHANGE 14325 NORTH 79TH ST.
SCOTTSDALE AZ 85260
K170261 PREMIUM PLUS INTERNATIONAL LIMITED FLAT 1001 YUEN LONG TRADING CENTRE, 33 WANG YIP STREET WEST
HONG KONG
K073353 PRODRIVE SYSTEMS, INC. 812 COMMERCE DR.
OGDENSBURG NY 13669
K090369 PRODRIVE SYSTEMS, INC. 812 COMMERCE DR.
OGDENSBURG NY 13669
K062219 PRODRIVE SYSTEMS, INC. 6062 ARMSTRONG RD.
SPENCERVILLE, ONTARIO K0E 1X0
K981869 PROFESSIONAL DENTAL MFG., INC. 633 LAWRENCE ST.
BATESVILLE AR 72501
K080240 PROMIDENT LLC 242 NORTH MAIN ST.
NEW CITY NY 10956
K092933 REDENT-NOVA LTD. COLUMBIA SQUARE
WASHINGTON DC 20004
K093084 ROLENCE ENT. INC. NO.58,FU CHIUN STREET
HSIN CHU CITY 30067
K072554 SABLE INDUSTRIES, INC. 581 WHILES COURT
ERIE CO 80516
K083101 SABLE INDUSTRIES, INC. 16576 W. 53rd way
Golden CO 80403
K221741 Saeshin Precision Co., Ltd. #52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun
Daegu 42921
K110379 SATELEC 124 GAITHER DRIVE
MT. LAUREL NJ 08054
K071965 SATELEC 124 GAITHER DRIVE
MT. LAUREL NJ 08054
K042787 SATELEC 130 GAITHER DRIVE
MT. LAUREL NJ 08054
K000049 SATELEC 70 WALNUT ST.
WELLESLEY MA 02481
K062418 SCICAN 1440 DON MILLS RD.
TORONTO, ONTARIO M3B 3P9
K071891 SCICAN LTD. 1440 DON MILLS RD.
TORONTO, ONTARIO M3B 3P9
K073319 SCICAN LTD. 1440 DON MILLS RD.
TORONTO, ONTARIO M3B 3P9
K063110 SHANGHAI DENTAL INSTRUMENT FACTORY 845 ARONSON LAKE COURT
ROSWELL GA 30075
K212910 Shenzhen Carejoy Technology Co., Ltd. 5 / F, Building E, No.10, East Snow Science And Technology,
Shenzhen 518129
K972436 SIEMENS AG 49 PLAIN ST.
NORTH ATTLEBORO MA 02760
K033812 SIRONA DENTAL SYSTEMS GMBH 49 PLAIN ST.
NORTH ATTLEBORO MA 02760-4153
K131319 SIRONA DENTAL SYSTEMS GMBH FABRIKSTRASSE 31
BENSHEIM D-64625
K955654 SPINTECH, INC. 218 DEW DROP RD.
YORK PA 17402
K093341 SYBRON DENTAL SPECIALTIES, INC. 1717 WEST COLLINS AVE.
ORANGE CA 92867
K073478 SYBRON DENTAL SPECIALTIES, INC. 1717 W. COLLINS AVE.
ORANGE CA 92867
K052822 THUNDER TIGER CORP. 58 FU-CHIUN STREET
HSIN CHU CITY 300
K062812 THUNDER TIGER CORP. 58 FU-CHIUN STREET
HSIN CHU CITY 300
K102517 THUNDER TIGER CORP. NO. 7, 6TH ROAD
TAICHUNG 40755
K190508 TTBIO CORP. 2F, No.7, 6th Road Industry Park
Taichung 40755
K141183 TTBIO CORP. 2F, NO.7, 6TH ROAD INDUSTRY PARK
TAICHUNG, ROC 40755
K232243 Ttbio Corp. 2F., No.7, 6th Road Industry Park
Taichung 40755
K992380 ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH
SOUTH JORDAN UT 84095
K143704 W & H Dentalwerk Buermoos GmbH Ignaz-Glaser-Strasse 53
Buermoos 5111
K090548 W & H DENTALWERK BUERMOOS GMBH IGNAZ GLASER STR. 53
BUERMOOS A-5111
K171553 W & H Dentalwerk Buermoos GmbH Ignaz-Glaser-StraBe 53
Buermoos 5111
K242179 W&H Dentalwerk Bⁿrmoos GmbH Ignaz-Glaser-Stra▀e 53
Bⁿrmoos 5111
K162926 W&H DENTALWERK BURMOOS GMBH IGNAZ-GLASER-STRABE 53
Bⁿrmoos 5111




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