FDA 510(k) Applications for Medical Device:
Drill, Bone, Powered
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K192033 | Bennett Jacoby, DDS, MS, Inc. |
77-6425 Kuakini Hwy, C2-84 | Kailua Kona | HI | 96740 |
| K080761 | BONART CO. LTD. |
398 S. LEMON CREEK DR. | WALNUT | CA | 91789 |
| K152125 | BONART CO., LTD. |
4F-1, NO. 3 WUQUAN 1ST RD. | XINZHUANG DIST. | 24892 | |
| K121620 | DMETEC CO., LTD. |
4568 W. 1ST STREET | LOS ANGELES | CA | 90004 |
| K113152 | DMETEC CO., LTD. |
1415-1441 GARDENA AVE. | GLENDALE | CA | 91204 |
| K150076 | DONG IL TECHNOLOGY LTD. |
28 NAMYANG-RO 930BEON-GIL | HWASEONG-SI, GYEONGGI-DO | 445-040 | |
| K110881 | DONG IL TECHNOLOGY LTD. |
300 ATWOOD | PITTSBURGH | PA | 15213 |
| K072146 | E.M.S. ELECTRO MEDICAL SYSTEMS S.A. |
49 PLAIN ST | NORTH ATTLEBORO | MA | 02760 |
| K240340 | Guangdong Jinme Medical Technology Co., Ltd. |
Room 301, 401, 501, Block No.3, Wanyang Science Park, 84 | Foshan | 528200 | |
| K111290 | GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD |
7325 JOYCE WAY | ECHO | OR | 97826 |
| K231087 | Implant Direct Sybron Manufacturing, LLC |
3050 East Hillcrest Drive | Thousand Oaks | CA | 91362 |
| K200265 | Implant Direct Sybron Manufacturing, LLC |
3050 East Hillcrest Drive | Thousand Oaks | CA | 91362 |
| K080220 | ITALIA MEDICA S.R.L. |
110 E. GRANADA BLVD. SUITE 207 | ORMOND BEACH | FL | 32176 |
| K060270 | LINVATEC CORP. |
11311 CONCEPT BLVD. | LARGO | FL | 33773-4908 |
| K032607 | LINVATEC CORP. |
11311 CONCEPT BLVD. | LARGO | FL | 33773-4908 |
| K171326 | Mectron S.p.a |
via loreto 15 | Carasco | 16042 | |
| K242432 | Mectron S.p.A. |
Via Loreto 15/A | Carasco | 16042 | |
| K122322 | MECTRON S.P.A. |
PIAZZA ALBANIA 10 | ROME | 00153 | |
| K171958 | Mectron SPA |
Via Loreto 15 | Carasco | 16042 | |
| K151248 | MECTRON SPA |
VIA LORETO 15 | CARASCO | 16042 | |
| K073678 | NAKANISHI, INC. |
1425 K STREET, N.W. | WASHINGTON | DC | 20005 |
| K990846 | NOBEL BIOCARE UAS INC |
22895 EASTPARK DR. | YORBA LINDA | CA | 92887 |
| K042434 | NOUVAG AG |
REUSSWEHRSTRASSE 1 | GEBENSTORF | 5412 | |
| K091227 | PIEZOSURGERY S.R.L. |
VIA ALDO MORO 20 | BRESCIA | 25124 | |
| K043408 | PIEZOSURGERY SRL |
PIAZZA ALBANIA 10 | ROME | 00153 | |
| K151171 | SAESHIN PRECISION CO., LTD. |
52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun | Daegu | 711-814 | |
| K192561 | Saeshin Precision Co., Ltd. |
52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun | Daegu | 42921 | |
| K091252 | SATELEC |
124 GAITHER DRIVE | MT. LAUREL | NJ | 08054 |
| K060274 | SATELEC |
130 GAITHER DRIVE | MT. LAUREL | NJ | 08054 |
| K091331 | SATELEC |
124 GAITHER DRIVE | MT. LAUREL | NJ | 08054 |
| K172137 | Satelec - Acteon Group |
17 Avenue Gustave Eiffel | Merignac | 33708 | |
| K112188 | SATELEC - ACTEON, INC. |
124 GAITHER DR., SUITE 140 | MOUNT LAUREL | NJ | 08054 |
| K072030 | SATELEC-ACTEON GROUP |
124 GAITHER DRIVE , SUITE 140 | MT LAUREL | NJ | 08054 |
| K083569 | SILFRADENT S.R.L. |
110 E. GRANADA BLVD., STE. 207 | ORMOND BEACH | FL | 32176 |
| K082532 | STRAUMANN USA |
60 MINUTEMAN ROAD | ANDOVER | MA | 01810 |
| K954690 | STRYKER CORP. |
2725 FAIRFIELD RD. | KALAMAZOO | MI | 49003-4085 |
| K991696 | STRYKER INSTRUMENTS |
4100 EAST MILHAM AVE. | KALAMAZOO | MI | 49001 |
| K032117 | STRYKER INSTRUMENTS |
4100 EAST MILHAM AVE. | KALAMAZOO | MI | 49001 |
| K082649 | SYNTHES (USA) |
1301 GOSHEN PKWY. | WEST CHESTER | PA | 19380 |
| K133488 | W & H DENTALWERK BUERMOOS GMBH |
IGNAZ-GLASER-STRASSE 53 | BUERMOOS, SALZBURG | 5111 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
