FDA 510(k) Applications for Medical Device:
Implant, Endosseous, Orthodontic
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K061397 | ACE SURGICAL SUPPLY CO., INC. |
1034 PEARL ST. | BROCKTON | MA | 02301 |
| K063770 | ALPHA-BIO TEC LTD |
5335 WISCONSIN AVE. NW | WASHINGTON | DC | 20015 |
| K190871 | Bio Cetec Co., Ltd. |
RM 1001-1002 New T Castle, 108, Gasan digital 2-ro | Seoul | 08506 | |
| K063495 | BIOMATERIALS KOREA INC. |
13 RED FOX LANE | LITTLETON | CO | 80127 |
| K111809 | BIOMATERIALS KOREA INC. |
5401 S. COTTONWOOD CT. | GREENWOOD VILLAGE | CO | 80121 |
| K222245 | BioMaterials Korea, Inc |
#329, #331, #413 150, Jojeong-daero | Hanam-si | 12930 | |
| K173623 | BioMaterials Korea, Inc |
#413, #329, #331 150, Jojeong-daero | Hanam-si | 12930 | |
| K201919 | Blue Sky Bio, LLC. |
800 Liberty Drive | Libertyville | IL | 60048 |
| K202278 | Bomei Co, Ltd. |
4F., No.1492-2, Chunrih Rd., Taoyuan Dist. | Taoyuan City | 33051 | |
| K152297 | BOMEI CO., LTD |
4F., NO.1492-2, CHUNRIH RD., TAOYUAN DIST. | TAOYUAN CITY | 33051 | |
| K113650 | BONAFIX SURGICAL AND DENTAL IMPLANTS, LLC |
118 W. PRIVE CR. | DELRAY TEZAK | FL | 33445 |
| K202691 | Craniofacial Technologies, Inc. |
98 Buckskin Road | West Hills | CA | 91307 |
| K120861 | CREEKSIDE ORTHODONTICS |
136 E. MALLARD DR. | BOISE | ID | 83706 |
| K100633 | D B ORTHODONTICS LTD |
RYEFIELD WAY | WEST YORKSHIRE | BD20 OEF | |
| K072086 | D B ORTHODONTICS LTD |
RYEFIELD WAY | WEST YORKSHIRE | BD20 0EF | |
| K130476 | DENTAL MORELLI |
18851 NE 29TH AVE 720 | AVENTURA | FL | 33180 |
| K062732 | DENTAURUM |
10 PHEASANT RUN | NEWTOWN | PA | 18940 |
| K062733 | DENTAURUM |
10 PHEASANT RUN | NEWTOWN | PA | 18940 |
| K042965 | DENTAURUM, INC. |
10 PHEASANT RUN | NEWTOWN | PA | 18940 |
| K181142 | Dentos Inc |
41, Seongseo-ro 68-gil, Dalseo-gu | Daegu | 42697 | |
| K110275 | FORESTADENT BERNHARD FORSTER GMBH |
962 ALLEGRO LANE | APOLLO BEACH | FL | 33572 |
| K081393 | G & H WIRE CO. |
11460 NORTH MERIDIAN STREET | CARMEL | IN | 46032 |
| K191041 | GNI Co., LTD |
5F 501, 63-12 Dongtancheomdansaneop 1-RO | Hwaseong | 18469 | |
| K091390 | HDC S.R.L. |
VIA BORGO SANTA CRISTINA,12 | IMOLA, BOLOGNA | 4026 | |
| K060062 | INSTITUT STRAUMANN AG |
60 MINUTEMAN ROAD | ANDOVER | MA | 01810 |
| K161335 | JEIL MEDICAL CORPORATION |
702, 703, 704, 705, 706, 804, 805, 807, 812-HO, 55, | SEOUL | 08378 | |
| K102769 | JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S |
11234 EL CAMINO REAL | SAN DIEGO | CA | 92130 |
| K122069 | LANCER ORTHODONTICS, INC. |
2330 Cousteau Court | Vista | CA | 92081 |
| K071490 | LEONE SPA |
50, VIA P. A QUARACCHI | SESTO, FIORENTINO | I-50019 | |
| K073461 | M.I.S. IMPLANTS TECHNOLOGIES LTD. |
P.O.B. 110 | SHLOMI | 22832 | |
| K182929 | Microware Precision Co., Ltd. |
No. 12, Keyuan 2nd Rd., Situn District | Taichung | 40763 | |
| K210559 | MK Meditech Inc. |
Room# 511, 54, Changeop-ro, Sujeong-gu, | Seongnam-si | 13449 | |
| K061266 | ORTHO ORGANIZERS, INC. |
11234 EL CAMINO REAL | SAN DIEGO | CA | 92130 |
| K161197 | OSSTEM IMPLANT CO., LTD. |
66-16, BANSONG-RO 513BEON-GIL, HAEUNDAE-GU | BUSAN | 612-070 | |
| K103105 | OSSTEM IMPLANT CO.,LTD |
85 BEN FAIRLESS DR. | FAIRLESS HILLS | PA | 19030 |
| K211992 | Osteonic Co., Ltd. |
303Ho, 405Ho, 505-2Ho, 505-3Ho, 902Ho, 1004Ho, 1201Ho | Guro-gu | 08381 | |
| K110392 | PSM MEDICAL SOLUTIONS |
SCHWARZWALDSTRASSE 5 | TUTTLINGEN BW | 78532 | |
| K982509 | STRAUMANN USA |
RESERVOIR PLACE, | WALTHAM | MA | 02154 |
| K061230 | SYBRON DENTAL SPECIALTIES |
100 BAYVIEW CIRCLE | NEWPORT BEACH | CA | 92660-8915 |
| K090476 | SYNTEC SCIENTIFIC CORP. |
3F1. 96 CHUNG HSIAO E. RD. | TAIPEI | 106 | |
| K202790 | Syntec Scientific Corporation |
No.2, Kung San Road Chuan Shing Industrial Zone, Shen Kang | Chang Hua | 50971 | |
| K142001 | SYNTEC SCIENTIFIC CORPORATION - TAIPEI OFFICE |
3F., NO. 96, SEC. 3, ZHONGXIO EAST ROAD DA'AN DIST., | TAIPEI | 10652 | |
| K063473 | SYNTHES (USA) |
1301 GOSHEN PKWY | WEST CHESTER | PA | 19380 |
| K093299 | SYNTHES (USA) |
1301 GOSHEN PKWY. | WEST CHESTER | PA | 19380 |
| K063149 | T.O.A.D.S., LLC. |
1226 ROWAN ST. | LOUISVILLE | KY | 40203 |
| K040469 | THE STRAUMANN CO. |
RESERVOIR PL. 1601 TRAPELO RD. | WALTHAM | MA | 02451 |
| K063386 | WALTER LORENZ SURGICAL, INC. |
1520 TRADEPORT DR. | JACKSONVILLE | FL | 32218 |
| K202163 | Ze Fang Technology Co., Ltd. |
No.17, Aly. 81, Ln. 2, Sec. 1, Zhongxing Rd., Dali Dist., | Taichung | 412 |
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