FDA 510(k) Applications for Medical Device:
Handpiece, Direct Drive, Ac-Powered
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K033597 | ADVANCED TECHNOLOGY RESEARCH (A.T.R.) S.R.L. |
VIA GIOVANNI VERGA, 7 | PISTOIA | 51100 | |
| K041279 | ANTHOGYR |
164 RUE DE TROIS LACS | SALLANCHES | 74700 | |
| K082325 | APEXUM LTD. |
6 YONI NETANYAHU ST. | OR-YEHUDA | ||
| K111078 | ASEPTICO, INC. |
8333 216TH ST., S.E. | WOODINVILLE | WA | 98072 |
| K142124 | ASEPTICO, INC. |
8333 216th St SE | WOODINVILLE | WA | 98072 |
| K150129 | Aseptico, Inc. |
8333 216th St. S.E. | Woodinville | WA | 98072 |
| K030163 | ASEPTICO, INC. |
8333 216TH ST., S.E. | WOODINVILLE | WA | 98072 |
| K103399 | ASEPTICO, INC. |
8333 216TH ST., S.E. | WOODINVILLE | WA | 98072 |
| K091913 | BY DENTAL SRL |
VIA VECCHIA PROV. LE LUCCHESE | SERRAVALLE POLI; PISTOIA | 51030 | |
| K191276 | ChangZhou BoMedent Medical Technology Co., Ltd. |
No.9 Changyang Road, West Taihu Science and | ChangZhou | 213000 | |
| K201993 | Changzhou Sifary Medical Technology Co., Ltd. |
No. 99, Qingyang Road, Xuejia County, Xinbei District | Changzhou City | 213000 | |
| K092833 | DENTAMERICA |
18688 E SAN JOSE AVE | INDUSTRY | CA | 91748 |
| K110753 | DENTSPLY INTERNATIONAL, INC. |
221 WEST PHILADELPHIA ST. | YORK | PA | 17404 |
| K092614 | DENTSPLY INTERNTIONAL |
221 W. PHILADELPHIA ST. STE.60 | YORK | PA | 17404 |
| K160825 | DENTSPLY SIRONA |
221 WEST PHILADELPHIA STREET | York | PA | 17404 |
| K101612 | DISCUS DENTAL, LLC |
8550 HIGUERA ST. | CULVER CITY | CA | 90232 |
| K180953 | DMS Co., Ltd. |
#201 #202 & #204, Oriental Medical Industry | Wonju-si | 26339 | |
| K192649 | Foshan CICADA Dental Instrument Co., Ltd. |
B5-2F, Guangdong New Light Source Industrial Base | Nanhai District, Foshan | ||
| K220829 | Foshan COXO Medical Instrument Co., Ltd. |
BLDG 4, District A, Guangdong New Light Source | Foshan | 528226 | |
| K211531 | Guilin Woodpecker Medical Instrument Co., Ltd. |
Information Industrial Park, Guilin National High-Tech Zone | Guilin | 541004 | |
| K203320 | Guilin Woodpecker Medical Instrument Co., Ltd. |
Information Industrial Park, Guilin National High-Tech Zone | Guilin | 541004 | |
| K180527 | Hiossen, Inc. |
85 Ben Fairless Dr. | Fairless Hills | PA | 19030 |
| K033689 | INTEGRATION DIAGNOSTICS LTD |
719 A STREET NE | WASHINGTON | DC | 20002 |
| K003714 | INTEGRATION DIAGNOSTICS LTD |
6470 RIVERVIEW TERRACE | MINNEAPOLIS | MN | 55432 |
| K031204 | J. MORITA USA, INC. |
1425 K ST. N.W. | WASHINGTON | DC | 20005 |
| K173920 | J. Morita USA, Inc. |
9 Mason | Irvine | CA | 92618 |
| K071190 | J. MORITA USA, INC. |
1425 K ST. N.W. | WASHINGTON | DC | 20005 |
| K112665 | J. MORITA USA, INC. |
1425 K STREET NW | WASHINGTON | DC | 20005 |
| K970339 | J. MORITA USA, INC. |
9 MASON | IRVINE | CA | 92618 |
| K170275 | J. MORITA USA, INC. |
9 MASON | IRVINE | CA | 92618 |
| K031540 | LARES RESEARCH, INC. |
295 LOCKHEED AVE. | CHICO | CA | 95973 |
| K050612 | LIGHTSPEED TECHNOLOGY, INC. |
403 E RAMSEY SUITE 205 | SAN ANTONIO | TX | 78216 |
| K012944 | MEDITEAM AB |
GOTEBORGSVAGEN 74, | SAVEDALEN | S-433 63 | |
| K133298 | META BIOMED, INC. |
2600 MULLINIX MILL ROAD | MT. AIRY | MD | 21771 |
| K210475 | Meta Systems Co., Ltd |
#1214-18, Sicox tower 12F, 484, Dunchon-daero, Jungwon-gu | Seongnam-si | 13229 | |
| K153285 | META SYSTEMS CO., LTD. |
RM 607, BYUCKSAN DIGITAL VALLEY 6, 219 | SEOUL | 08501 | |
| K161500 | MICRO-NX Co., Ltd |
37, Dalseong2chadong 3-ro, Guji-myeon, Dalseong-gun | Daegu | 711-891 | |
| K110278 | NAKANISHI, INC. |
1201 RICHARDSON DRIVE | RICHARDSON | TX | 75080 |
| K131578 | NAKANISHI, INC. |
1201 RICHARDSON DRIVE | RICHARDSON | TX | 75080 |
| K081191 | NOUVAG AG |
REUSSWEHRSTRASSE 1 | GEBENSTORF | CH-5412 | |
| K042822 | NOUVAG AG |
REUSSWEHRSTRASSE 1 | GEBENSTORF | 5412 | |
| K990646 | NSK NAKANISHI, INC. |
340 KAMIHINATA,KANUMA-SHI | TOCHIGI-KEN | 322 | |
| K990682 | NSK NAKANISHI, INC. |
340 KAMIHINATA,KANUMA-SHI | TOCHIGI-KEN | 322 | |
| K132401 | OSSTELL AB |
901 KING STREET | ALEXANDRIA | VA | 22314 |
| K181888 | Osstell AB |
Stampgaten 14 | Gotenborg | 41101 | |
| K142358 | OSSTELL AB |
STAMPGATAN 14 | GOTHENBURG | 41101 | |
| K082523 | OSSTELL AB |
901 KING STREET | ALEXANDRIA | VA | 22314 |
| K983413 | PARKELL, INC. |
155 SCHMITT BLVD. | FARMINGDALE | NY | 11735 |
| K232657 | Perimetrics, Inc |
360 San Miguel, Suite 204 | Newport Beach | CA | 92600 |
| K072213 | PERIMETRICS, INC. |
27001 LA PAZ, SUITE 314 | MISSION VIEJO | CA | 92691 |
| K993188 | PHYTRON- ELEKTRONIK GMBH |
INDUSTRIESTRASSE 12 | GROBENZELL | ||
| K180682 | Premier Dental Company Products |
1710 Romano Drive | Plymouth Meeting | PA | 19462 |
| K111616 | SAESHIN PRECISION CO., LTD. |
#93-15, PAHO-DONG, DALSEO-GU | DAEGU | 704-220 | |
| K212043 | Saeshin Precision Co., Ltd. |
# 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun | Daegu | 711-814 | |
| K143411 | SAESHIN PRECISION CO., LTD. |
52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun | Daegu | 711814 | |
| K123582 | SAEYANG MICROTECH CO., LTD |
55 NORTHERN BLVD | GREAT NECK | NY | 11021 |
| K213897 | Saeyang Microtech Co., Ltd. |
348, Seongseo-ro | Daegu | 41065 | |
| K222548 | Shenzhen Perfect Medical Instruments Co., Ltd. |
Room 102, Building A, Ruiji Factory, No. 3 Zaohekeng, | Shenzhen | 518100 | |
| K051661 | SIRONA DENTAL SYSTEMS GMBH |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760-4153 |
| K052515 | SIRONA DENTAL SYSTEMS GMBH |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760-4153 |
| K990739 | SYBRON DENTAL SPECIALTIES, INC. |
1717 WEST COLLINS AVE. | ORANGE | CA | 92867 |
| K143445 | Tellos Medical AB |
Nedergardsgatan 5 | Goteborg | 41654 | |
| K090931 | W & H DENTALWERK BUERMOOS GMBH |
53 IGNAZ-GLASER-STRASSE | BUERMOOS, SALZBURG | A-5111 | |
| K100600 | W & H DENTALWERK BUERMOOS GMBH |
53 IGNAZ-GLASER-STRASSE | BUERMOOS | 5111 | |
| K201703 | W&H Dentalwerk Buermoos GmbH |
Ignaz Glaser Strasse 53 | Buermoos | AT - 5111 | |
| K063007 | WESTPORT MEDICAL, INC. |
6603 RIPPLING BROOK DRIVE SE | SALEM | OR | 97317 |
| K171377 | Young Dental Manufacturing Co 1, LLC |
13705 Shoreline CtEast | Earth City | MO | 63045 |
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