FDA 510(k) Applications for Medical Device:
Scaler, Ultrasonic
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K992504 | (EMS SA) ELECTRO MEDICAL SYSTEMS |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K991874 | (EMS SA) ELECTRO MEDICAL SYSTEMS |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K100647 | A-DEC, INC. |
2601 CRESTVIEW DR. | NEWBERG | OR | 97132-9257 |
| K982793 | ADVANCED MEDICAL DEVICES, INC. |
3722 AVE SAUSALITO | IRVINE | CA | 92606 |
| K002122 | AIR TECHNIQUES, INC. |
70 CANTIAGUE ROCK RD. | HICKSVILLE | NY | 11801 |
| K122501 | AMERICAN EAGLE INSTRUMENTS, INC. |
6575 BUTLER CREEK ROAD | MISSOULA | MT | 59808 |
| K042972 | AMERICAN EAGLE INSTRUMENTS, INC. |
6575 BUTLER CREEK RD. | MISSOULA | MT | 59808 |
| K033044 | AMERICAN GREEN DENT. MFG, INC. |
3432 E. 14TH STREET | LOS ANGELES | CA | 90023 |
| K033198 | APOZA ENTERPRISE CO. LTD. |
6 F,NO.657, CHUANG CHENG ROAD | TAIPEI HSIEN | 242 | |
| K130693 | ASEPTICO, INC. |
8333 216th St SE | WOODINVILLE | WA | 98072 |
| K070866 | ASEPTICO, INC. |
8333 216TH ST., S.E. | WOODINVILLE | WA | 98072 |
| K123139 | ASI MEDICAL, INC. |
14550 E EASTER AVE. | CENTENNIAL | CO | 80112 |
| K000510 | BONART CO. LTD. |
RM. 405, NO.3 WUCHUAN 1ST ROAD | HSINCHUANG, TAIPEI | ||
| K994203 | BONART CO. LTD. |
RM. 405, NO.3 WUCHUAN 1ST ROAD | HSINCHUANG, TAIPEI | ||
| K994299 | BONART CO. LTD. |
RM. 405, NO.3 WUCHUAN 1ST ROAD | HSINCHUANG, TAIPEI | ||
| K052028 | BONART CO. LTD. |
398 S. LEMON CREEK DR. | WALNUT | CA | 91789 |
| K061448 | BONART CO. LTD. |
398 S. LEMON CREEK DR. | WALNUT | CA | 91789 |
| K071981 | BONART CO. LTD. |
398 S. LEMON CREEK DR. | WALNUT | CA | 91789 |
| K081550 | BONART CO. LTD. |
398 S. LEMON CREEK DR. | WALNUT | CA | 91789 |
| K130834 | CEFLA S.C. |
110 E. GRANADA BLVD. | ORMOND BEACH | FL | 32176 |
| K213947 | ChangZhou BoMedent Medical Technology Co.,Ltd |
No.9 Changyang Road,West Taihu Science & Technology | Changzhou | 213100 | |
| K130137 | COLTENE/WHALEDENT |
5905 LAWN LANE | CLEVELAND | OH | 44141 |
| K983727 | COLTENE/WHALEDENT INC. |
750 CORPORATE DR. | MAHWAH | NJ | 07430-2009 |
| K943403 | CONDOR PRODUCTS, INC. |
4860 VIA PIEDRA | YORBA LINDA | CA | 92686 |
| K051910 | D.B.I. AMERICA CORP. |
2909 BUSCH LAKE BLVD. | TAMPA | FL | 33614 |
| K011179 | DELDENT LTD. |
19 KEREN KAYEMET ST. | PETACH TIKVAH | 49372 | |
| K014238 | DELDENT LTD. |
19 KEREN KAYEMET ST. | PETACH TIKVAH | 49372 | |
| K242317 | Denjoy Dental Co., Ltd. |
F4, Building A4, Lugu Medical Device Park, No.229 | Changsha | 410205 | |
| K240801 | Dent4You AG |
Bahnhofstrasse 2 | Heerbrugg | 9435 | |
| K954820 | DENTAMERICA |
P.O. BOX 3200 | INDUSTRY | CA | 91744 |
| K033705 | DENTSPLY INTERNATIONAL |
570 WEST COLLEGE AVE. | YORK | PA | 17404 |
| K030111 | DENTSPLY INTERNATIONAL |
570 WEST COLLEGE AVE. | YORK | PA | 17405 |
| K023697 | DENTSPLY INTERNATIONAL |
P.O. BOX 872 | YORK | PA | 17405 |
| K150535 | DENTSPLY INTERNATIONAL, INC. |
221 WEST PHILADELPHIA ST. | YORK | PA | 17401 |
| K070307 | DENTSPLY INTERNATIONAL, INC. |
221 W. PHILADELPHIA ST., SE 60 | YORK | PA | 17404 |
| K082973 | DENTSPLY INTERNTIONAL |
221 W. PHILADELPHIA ST. STE.60 | YORK | PA | 17405 |
| K031461 | DENTSPLY INTL. |
570 WEST COLLEGE AVE. | YORK | PA | 17405-0872 |
| K970342 | DENTSPLY INTL. |
570 WEST COLLEGE AVE. | YORK | PA | 17405-0872 |
| K052334 | DENTSPLY INTL. |
221 WEST PHILADELPHIA STREET | YORK | PA | 17404 |
| K970123 | DENTSPLY INTL. |
570 WEST COLLEGE AVE. | YORK | PA | 17405-0872 |
| K130862 | DENTSPLY INTL., INC. |
221 WEST PHILADELPHIA STREET | YORK | PA | 17404 |
| K051776 | DISCUS DENTAL INC. |
8550 HIGUERA ST. | CULVER CITY | CA | 90232 |
| K092417 | DISCUS DENTAL, LLC |
8550 HIGUERA ST. | CULVER CITY | CA | 90232 |
| K060171 | DMETEC CO., LTD. |
55 NORTHERN BLVD., SUITE 200 | GREAT NECK | NY | 11021 |
| K170104 | DMETEC CO., LTD. |
#402-603. Techno-Park, 193, Yakdae-Dong, Wonmi-Ku, Bucheon | Gyeonggi-do | ||
| K083059 | DPM USA CORP. |
1460 NW 107 AVE. SUITE G | MIAMI | FL | 33172 |
| K191079 | E.M.S Electro Medical Systems S.A |
Chemin de la Vuarpilliere 31 | Nyon | CH-1260 | |
| K190124 | E.M.S Electro Medical Systems S.A. |
Chemin de la Vuarpilliere 31 | Nyon | CH-1260 | |
| K140990 | E.M.S. ELECTRO MEDICAL SYSTEMS S.A. |
62 FOREST ST., STE 300 | MARLBOROUGH | MA | 01752 |
| K050710 | E.M.S. ELECTRO MEDICAL SYSTEMS S.A. |
49 PLAIN STREET | NORTH ATTLEBORO | MA | 02760 |
| K132443 | E.M.S. ELECTRO MEDICAL SYSTEMS S.A. |
62 FOREST ST., STE 300 | MARLBOROUGH | MA | 01752 |
| K132445 | E.M.S. ELECTRO MEDICAL SYSTEMS S.A. |
62 FOREST ST., STE 300 | MARLBOROUGH | MA | 01752 |
| K022328 | ELECTRO MEDICAL SYSTEMS SA |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K110173 | EMS ELECTRO MEDICAL SYSTEMS SA |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K093723 | EMS ELECTRO MEDICAL SYSTEMS SA |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K093000 | EMS ELECTRO MEDICAL SYSTEMS SA |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K182145 | Engineered Endodontics |
W134 N4965 Campbell Drive | Menomonee Falls | WI | 53051 |
| K122748 | ENGLER ENGINEERING CORP. |
1099 EAST 47TH ST. | HIALEAH | FL | 33013 |
| K223340 | Essential Dental Systems Inc. |
89 Leuning Street | South Hackensack | NJ | 07606 |
| K132609 | ESSENTIAL DENTAL SYSTEMS, INC. |
89 LEUNING STREET | SOUTH HACKENSACK | NJ | 07606 |
| K222096 | Foshan COXO Medical Instrument Co.,Ltd. |
BLDG 4,District A Guangdong New Light Source Industrial | Foshan | 528226 | |
| K230641 | Guilin Refine Medical Instrument Co., Ltd. |
No.8-3, Information Industrial Park, High-Tech Zone, | Guilin | 541004 | |
| K053555 | GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD |
340 SHADY GROVE ROAD | FLINTVILLE | TN | 37335 |
| K203615 | Guilin Woodpecker Medical Instrument Co., Ltd. |
Information Industrial Park, Guilin National High-Tech Zone | Guilin | 541004 | |
| K100401 | HU-FRIEDY MFG. CO., INC |
3232 N. ROCKWELL STREET | CHICAGO | IL | 60618 |
| K070975 | HU-FRIEDY MFG. CO., INC |
3232 N. ROCKWELL STREET | CHICAGO | IL | 60618 |
| K012060 | HU-FRIEDY MFG. CO.,INC. |
3232 NORTH ROCKWELL ST. | CHICAGO | IL | 60618 |
| K053178 | HU-FRIEDY MFG. CO.,INC. |
3232 NORTH ROCKWELL ST. | CHICAGO | IL | 60618 |
| K042056 | J. MORITA USA, INC. |
9 MASON | IRVINE | CA | 92618 |
| K053030 | J. MORITA USA, INC. |
9 MASON | IRVINE | CA | 92618 |
| K103498 | LAKONG MEDICAL DEVICE COMPANY, LTD |
18525 E. GALE AVE. | CITY OF INDUSTRY | CA | 91748 |
| K231391 | Mectron S.p.A. |
Via Loreto 15/A | Carasco | 16042 | |
| K102218 | MECTRON S.P.A. |
PIAZZA ALBANIA 10 | ROME | 00153 | |
| K151023 | MECTRON SPA |
VIA LORETO 15 | CARASCO | 16042 | |
| K140965 | MECTRON SPA |
PIAZZA ALBANIA, 10 | ROME | 00153 | |
| K081268 | MICRO-MEGA SOCIETE ANONYME |
5-12 RUE DU TUNNEL | CEDEX BESANCON | 25006 | |
| K032995 | MICRON CORP. |
1-34-14 HIGASHIYUKIGAYA | OTA-KU, TOKYO | 145-0065 | |
| K991239 | MICRON CORP. |
1-34-14 HIGASHIYUKIGAYA | OHTA-KU, TOKYO | 145-0065 | |
| K171150 | Micron Corporation |
2-17-7 Ikegami | Ota-ku, Tokyo | 146-0082 | |
| K161639 | MICRON CORPORATION |
2-17-7 IKEGAMI | Ota-ku, Tokyo | 146-0082 | |
| K113530 | NAKANISHI, INC. |
1201 RICHARDSON DRIVE | RICHARDSON | TX | 75080 |
| K113717 | NAKANISHI, INC. |
1201 RICHARDSON DRIVE | RICHARDSON | TX | 75080 |
| K031421 | NAKANISHI, INC. |
700B COOPER COURT | SCHAUMBURG | IL | 60173 |
| K062731 | NAKANISHI, INC. |
700 SHIMOHINATA | KANUMA-SHI, TOCHIGI-KEN | 322-8666 | |
| K071447 | NAKANISHI, INC. |
700 SHIMOHINATA | KANUMA-SHI, TOCHIGI-KEN | 322-8666 | |
| K140233 | NANNING BAOLAI MEDICAL INSTRUMENT CO., LTD. |
LEVEL 7, JIN GUI BUSINESS CENTER | GUANGZHOU, GUANGDONG | 510420 | |
| K163414 | NANNING VV DENTAL CO., LTD. |
4th floor,North Bld. No.1 , Zhengxin Tech Zone, No. 2, | Nan ning | 530007 | |
| K991021 | NSK NAKANISHI, INC. |
340 KAMIHINATA,KANUMA-SHI | TOCHIGI-KEN | 322 | |
| K233844 | Odne AG |
Ringstrasse 14 | Dⁿbendorf | 8600 | |
| K000846 | ORASYSTEMS |
764 SPEEDWELL AVE. | MORRIS PLAINS | NJ | 07950-2231 |
| K033120 | PAC-DENT INTERNATIONAL (SUZHOU), LTD. |
21078 COMMERCE POINT DR. | WALNUT | CA | 91789 |
| K052518 | PIEZOSURGERY SRL |
PIAZZA ALBANIA 10 | ROME | 00153 | |
| K010195 | PREMIER DENTAL PRODUCTS CO. |
3600 HORIZON DR. | KING OF PRUSSIA | PA | 19406 |
| K964596 | PROFESSIONAL DENTAL MFG., INC. |
P.O. BOX 4129 | BATESVILLE | AR | 72503 |
| K040396 | ROLENCE ENTEPRISE, INC. |
18-3, LANE 231 | CHUNGI | 320 | |
| K960889 | SAN DIEGO SWISS MACHINING, INC. |
8910 UNIVERSITY CENTER LN. | SAN DIEGO | CA | 92122-1085 |
| K060275 | SATELEC |
130 GAITHER DRIVE | MT. LAUREL | NJ | 08054 |
| K033764 | SATELEC |
Z.I. DU PHARE, B.P. 216 | MERIGNAC CEDEX | 33708 | |
| K972026 | SATELEC |
70 WALNUT ST. | WELLESLEY | MA | 02481 |
| K961158 | SATELEC |
70 WALNUT ST. | WELLESLEY | MA | 02481 |
| K050895 | SATELEC |
17 AVENUE GUSTAVE EIFFEL | MERIGNAC, GIRONDE | 33708 | |
| K131151 | SATELEC-ACTEON GROUP |
124 GAITHER DRIVE , SUITE 140 | MT LAUREL | NJ | 08054 |
| K131997 | SATELEC-ACTEON GROUP |
124 GAITHER DRIVE , SUITE 140 | MT LAUREL | NJ | 08054 |
| K132322 | SATELEC-ACTEON GROUP |
124 GAITHER DRIVE , SUITE 140 | MT LAUREL | NJ | 08054 |
| K132267 | SATELEC-ACTEON GROUP |
124 GAITHER DRIVE , SUITE 140 | MT LAUREL | NJ | 08054 |
| K071424 | SATELEC-ACTEON GROUP |
124 GAITHER DRIVE , SUITE 140 | MT LAUREL | NJ | 08054 |
| K113430 | SATELEC-ACTEON GROUP |
124 GAITHER DRIVE , SUITE 140 | MT LAUREL | NJ | 08054 |
| K233922 | SATELEC-ACTEON GROUP |
17 Avenue Gustave Eiffel | Merignac | 33708 | |
| K202906 | Schlumbohm GmbH & Co. KG |
Klein Floyen 8-10 | Brokstedt | D-24616 | |
| K053578 | SCORPION |
333 MILFORD ROAD | DEERFIELD | IL | 60015 |
| K990546 | SDS DENTAL, INC. |
5101 N.W. 21ST AVE. N.W. | FORT LAUDERDALE | FL | 33309 |
| K240707 | Shenzhen Micro Electric Intelligence Co., Ltd. |
301, Building A5, No. 13 Baonan Road, Longgang Community | Shenzhen | 518100 | |
| K050354 | SIRONA DENTAL SYSTEMS GMBH |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760-4153 |
| K072107 | SIRONA DENTAL SYSTEMS GMBH |
FABRIKSTRASSE 31 | BENSHEIM | D-64625 | |
| K033640 | SIRONA DENTAL SYSTEMS GMBH |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760-4153 |
| K203302 | Sonendo, Inc |
26061 Merit Circle, Suite 102 | Laguna Hills | CA | 92653 |
| K130025 | SONENDO, INC. |
26061 MERIT CIRCLE, SUITE 101 | LAGUNA HILLS | CA | 92653 |
| K153157 | SONENDO, INC. |
26061 MERIT CIRCLE, SUITE 102 | LAGUNA HILLS | CA | 92653 |
| K190359 | Sonendo, Inc. |
26061 Merit Circle | Laguna Hills | CA | 92653 |
| K143448 | Sonendo, Inc. |
26061 Merit Circle, Suite 102 | Laguna Hills | CA | 92653 |
| K160905 | SONENDO, INC. |
26061 MERIT CIRCLE, SUITE 102 | LAGUNA HILLS | CA | 92653 |
| K133752 | SONENDO, INC. |
26061 MERIT CIRCLE, SUITE 101 | LAGUNA HILLS | CA | 92653 |
| K002521 | SPARTAN MARKETING GROUP |
1663 FENTON BUSINESS PARK CT. | FENTON | MO | 63026 |
| K002753 | SPARTAN ULTRASONICS, INC. |
1663 FENTON BUSINESS PARK CT. | FENTON | MO | 63026 |
| K080089 | SYBRON DENTAL SPECIALTIES, INC. |
1717 W. COLLINS AVE. | ORANGE | CA | 92867 |
| K021253 | SYBRON ENDO/ANALYTIC |
1717 WEST COLLINS AVE. | ORANGE | CA | 92867 |
| K964320 | TONY RISO CO., INC. |
17070 COLLINS AVENUE #263 | MIAMI BEACH | FL | 33160 |
| K983029 | TPC ADVANCED TECHNOLOGY, INC. |
18140 SMOKESIGNAL DR. | SAN DIEGO | CA | 92127 |
| K051547 | TPC ADVANCED TECHNOLOGY, INC. |
17588 E. ROWLAND ST. | CITY OF INDUSTRY | CA | 91748 |
| K210832 | TTBIO CORP. |
2F, No.7, 6th Road, Industry Park | Taichung | 40755 | |
| K201317 | TTBIO CORP. |
2F, NO.7, 6TH Road Industry Park | Taichung | 40755 | |
| K062791 | ULTRASONIC SERVICES INC. |
7126 MULLINS DRIVE | HOUSTON | TX | 77081 |
| K223173 | W&H Dentalwerk Buermoss GmbH |
Ignaz-Glaser-Strasse 53 | Buermoos | 5111 |
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