FDA 510(k) Applications for Medical Device:
Handpiece, Contra- And Right-Angle Attachment, Dental
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K220346 | AJK Engineering, Inc. |
1605 Ashley Court | Sommerville | SC | 29486 |
| K103157 | ANGSTROM MFG., INC. |
6539 U.S. HWY. 61 | BLOOMSDALE | MO | 63627 |
| K103158 | ANGSTROM MFG., INC. |
6539 U.S. HWY. 61 | BLOOMSDALE | MO | 63627 |
| K111532 | ANTHOGYR SAS |
2237, AVENUE ANDRE LASQUIN | SALLANCHES | 74700 | |
| K020137 | ASEPTICO, INC. |
8333 216TH ST., S.E. | WOODINVILLE | WA | 98072 |
| K051077 | ASEPTICO, INC. |
8333 216TH ST., S.E. | WOODINVILLE | WA | 98072 |
| K162856 | Bonart Co., Ltd. |
NO. 80, WUXUAN ST., | KEELUNG CITY | 20446 | |
| K060377 | DENTAL RESOURCES |
400 CONGRESS ST. W. | MAPLE LAKE | MN | 55358 |
| K983574 | DENTALEZ GROUP |
1816 COLONIAL VILLAGE LN. | LANCASTER | PA | 17601 |
| K162397 | DENTALEZ, INC |
1816 COLONIAL VILLAGE LANE | Lancaster | PA | 17601 |
| K240183 | DentalEZ, Inc., StarDental Division |
1816 Colonial Village Lane | Lancaster | PA | 17601 |
| K133178 | DIRECTA AB |
P.O. BOX 723 | UPPLANDS VASBY | SE-194 47 | |
| K111541 | ESSENTIAL DENTAL SYSTEMS, INC. |
89 LEUNING STREET | SOUTH HACKENSACK | NJ | 07606 |
| K060317 | EST. ANTHOGYR |
164 RUE DES TROIS LACS | SALLANCHES | 74700 | |
| K092053 | HANDPIECE HEADQUARTERS |
620 S. PLACENTIA AVE. | PLACENTIA | CA | 92870 |
| K141125 | HANDPIECE HEADQUARTERS |
620 S. PLACENTIA AVE. | PLACENTIA | CA | 92870 |
| K103697 | J. MORITA USA, INC. |
1425 K STREET NW | WASHINGTON | DC | 20005 |
| K213139 | KaVo Dental GmbH |
Bismarckring 39 | Biberach | 88400 | |
| K220874 | Lares Research |
295 Lockheed Ave | Chico | CA | 95973 |
| K042171 | MICRO-MEGA SOCIETE ANONYME |
5-12 RUE DU TUNNEL | CEDEX BESANCON | 25006 | |
| K961494 | MICRO-MEGA SOCIETE ANONYME |
5-12 RUE DU TUNNEL | CEDEX BESANCON | 25006 | |
| K971350 | MICRO-MEGA SOCIETE ANONYME |
5-12 RUE DU TUNNEL | CEDEX BESANCON | 25006 | |
| K220577 | Micro-NX Co., Ltd. |
22 Maeyeo-ro 1 gil | Dong-gu | 41059 | |
| K973800 | MIDWEST DENTAL PRODUCTS CORP. |
901 WEST OAKTON ST. | DES PLAINES | IL | 60018 |
| K222518 | Nakanishi INC. |
700 Shimohinata | Kanuma | 322-8666 | |
| K202960 | Nakanishi Inc. |
700 Shimohnata | Kanuma | 322-8666 | |
| K182999 | Nakanishi Inc. |
700 Shimonhinata | Kanuma-shi | 322-8666 | |
| K230106 | Nakanishi Inc. |
700 Shimohinata | Kanuma | 322-8666 | |
| K121901 | NAKANISHI, INC. |
4-4-17 HONGO | BUNKYO-KU | 113-0033 | |
| K022505 | NOUVAG AG |
REUSSWEHRSTRASSE 1 | GEBENSTORF | 5412 | |
| K962540 | NSK NAKANISHI, INC. |
340 KAMIHINATA,KANUMA-SHI | TOCHIGI-KEN | 322 | |
| K972569 | NSK NAKANISHI, INC. |
340 KAMIHINATA,KANUMA-SHI | TOCHIGI-KEN | 322 | |
| K061897 | ORTHOSOURCE, INC. |
13343 SHERMAN WAY | NORTH HOLLYWOOD | CA | 91605 |
| K030603 | PAC-DENT INTERNATIONAL (SUZHOU), LTD. |
125 BINHE ROAD | JIANGSU PROVINCE | 215011 | |
| K240950 | Pacific Care Limited |
Unit 308-309, 15W, Hong Kong Science Park | N.T. | ||
| K100854 | PREMIUM PLUS INTERNATIONAL LIMITED |
33 WANG YIP STREET WEST | HONG KONG | ||
| K032925 | RONVIG A/S |
GL. VEJLEVEJ 57-59 | DAUGAARD | 8721 | |
| K100192 | SAESHIN PRECISION CO., LTD. |
#93-15, PAHO-DONG, DALSEO-GU | DAEGU | 704-220 | |
| K171436 | Saeshin Precision Co., Ltd. |
52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun | Daegu | 42921 | |
| K181129 | Saeshin Precision Co., Ltd. |
52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun | Daegu | 42921 | |
| K143418 | Saeshin Precision Co., Ltd. |
52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun | Daegu | 711-814 | |
| K182892 | Saeshin Precision Co., Ltd. |
52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun | Daegu | 42921 | |
| K132356 | SCICAN GMBH |
WANGENER STR. 78 | LEUTKIRCH | 88299 | |
| K150750 | Sirona Dental Systems GMBH |
Fabrikstrasse 31 | Bensheim | 64625 | |
| K023953 | ST. GEORGE TECHNOLOGY, INC. |
P.O. BOX 2849 | WILMINGTON | NC | 28402 |
| K022264 | SVENSKA DENTAL INSTRUMENTS AB |
PO BOX 723 | UPPLANDS VAESBY | 194 27 | |
| K994024 | TEAM TECHNOLOGIES, INC. |
5949 COMMERCE BLVD. | MORRISTOWN | TN | 37814 |
| K112305 | THUNDER TIGER CORP. |
NO. 7, 6TH ROAD | TAICHUNG | 40755 | |
| K011061 | W & H DENTALWERK BUERMOOS GMBH |
53 IGNAZ-GLAZER-STRASSE | BUERMOOS | 5111 |
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