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ADH12SHC
 Request for Information Form |
 Contact Information
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| Company Name | OSSTEM IMPLANT CO LTD |
| Address | 507-8 GEOJE 3-DONG YEONJE-GU |
| City, State, Zip | BUSAN, |
| Country | KS |
| FDA Owner/Operator Phone | 82-2-20167000 |
| FDA Medical Specialty Code | DE - Dental |
| FDA Product Code | NDP |
| FDA Classification Name | ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS |
| FDA Device Classification Code | General Controls |
| FDA Regulation Number | 872.3980 |
| FDA Common Generic Name | VARIOUS ACCESSORIES FOR ENDOSSEOUS DENTAL IMPLANTS |
| FDA Proprietary Device Name | ADH12SHC |
| FDA Owner / Operator Number | 9062743 |
| FDA Owner / Operator Name | OSSTEM IMPLANT CO LTD |
| FDA Establishment Registration Number | 3003394081 |
| FDA Registered Establishment Name | OSSTEM IMPLANT CO LTD |
| FDA Operation Code(s) |
MM - Manufacturer |
| FDA Listing Date | 06-27-06 |
| FDA Listing Status Code | Active |
| Differentiation | N/A |
| Keywords | N/A |
| Description | N/A |
| Brochure | N/A |
| Product Website | N/A |
Competitors of OSSTEM IMPLANT CO LTD
Our records indicate that the following medical device companies may manufacture a similar device.| Company Name / Address / Phone | Proprietary Device Name | Common Generic Device Name | |
| 1 | 3A MEDES #508 ILSANTECHNOTOWN BLDG. 1141-1 BAESEOK-DONG ILSAN-GU GOYANG-SI, GYEONGGI-DO, KS 82-31-9098776 / 267-210-9365 |
GASKET FOR SPLINT (SOFT/HARD) | ENDOSSEOUS DENTAL IMPLANT ACCESSORIES (EASY VAC GASKETS) |
| 2 | A.B. DENTAL DEVICES LTD D.N. EVTACH NIR GALIM, 79245 IS 972-885-31388 / 972-885-31388 |
"MULTIPLY" | ACCESSORIES, DENTAL IMPLANTS |
| 3 | ADOLF SCHWEICKHARDT GMBH & CO. KG 80 BAHNHOFSTRASSE TUTTLINGEN, D-78532 GM 49-74-61-9297-0 / 49-74-61-9297-0 |
MULTIPLE | VARIOUS TYPES OF DENTAL ENDOSSEOUS IMPLANT ACCESSORIES |
| 4 | AICHI STEEL CORP. 1, WANO-WARI, ARAO-MACHI TOKAI-SHI, AICHI-KEN, 476-8666 JA 81-52-603-9264 / 650-340-0393 |
MAGFIT IP | MAGFIT IP |
| 5 | ALPHA BIO TEC LTD. 7 EMBAR ST. I.Z. KIRYAT ARIE, POB 3936 PETACH-TIKVA, 49130 IS / 202-885-5548 |
ALPHA BIO SURGICAL INSTRUMENTS | SURGICAL INSTRUMENTS |
| 6 | ALTATEC GMBH MAYBACHSTRABE 5 WIMSHEIM, D-71299 GM 497-044-9445503 / 497-044-9445503 |
MULTIPLE | VARIOUS TYPES OF DENTAL IMPLANT ACCESSORIES AND KITS |
| 7 | APPLIED DENTAL INC. 465 FAIRCHILD DR., SUITE 202 MOUNTAIN VIEW, CA 94043 US 650-960-0313 / 650-960-0313 |
EZ STENT | DENTAL IMPLANT SURGICAL GUIDE |
| 8 | ASTRA TECH AB AMINOGATAN 1 MOLNDAL, S-431 21 SW 44-207-304 5000 / 46-31-7763000 |
MULTIPLE | VARIOUS TYPES OF INSTRUMENTS |
| 9 | ATTACHMENTS INTL., INC. 600 SOUTH AMPHLETT BLVD. SAN MATEO, CA 94402 US 714-516-7400 / 714-516-7484 |
MULTIPLE | DENTAL IMPLANT ACCESSORIES |
| 10 | AURUM CERAMIC DENTAL LABORATORIES (SASK.) LTD. 336 6TH AVE. N. SASKATOON, SASK, S7K 2S5 CA 306-665-8815 / 306-665-8815 |
MULTIPLE | IMPLANT PARTS |
| 11 | B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. LEONARDO DA VINCI 14 B MINANO(ALAVA), 01510 SP 34-945-297030 / 349-452-97030 |
PERIOSTEAL ADHESIVE REMOVER, SINUS ELEVATION INSTRUMENT, CIRCULAR PERFORATOR | VARIOUS TYPES AND SIZES OF DENTAL IMPLANT ACCESSORIES |
| 12 | BASIC DENTAL IMPLANT SYSTEMS, INC. 3321 COLUMBIA N.E. ALBUQUERQUE, NM 87107 US 505-881-1376 / 505-881-1376 |
DRILL EXTENDER | DRILL EXTENDER |
| 13 | BATCO - BRAZIL RUA ASIA, 173 SAO PAULO, SP, 05413-001 BR 55-11-83317633 / 55-11-83317633 |
OSSEOUS (DRIVERS, ANALOG HOLDER, RIGHT ANGLE DRIVER AND PLACEMENT TOOLS) | DRIVERS, HOLDERS AND PLACEMENT TOOLS |
| 14 | BIOMET 3I, INC. 4555 RIVERSIDE DR. PALM BEACH GARDENS, FL 33410 US 561-776-6700 6819 / 561-776-6700 |
ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS | RADIOGRAPHIC MARKING BALLS, BONE/TISSUE COLLECTORS |
| 15 | BIONNOVATION SA 1275, LAUREANO GARCIA BAURU, SP, 17039-760 BR 55-14-2312423 / 55-14-31032400 |
ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS (MULTIPLE BRANDS) | VARIOUS TYPES OF DENTAL IMPLANTS |
| 16 | BRAINBASE CORPORATION NO. 1-22-13 OI, SHINAGAWA-KU TOKYO, 140-0014 JA 81-337-780745 / 925-973-0710 202 |
FIT-SYSTEM | DENTAL IMPLANT ACCESSORIES |
| 17 | COASTAL BIOCARE 2737 SOUTH CRODDY WAY UNIT D SANTA ANA, CA 92704 US 714-751-0121 / 714-751-0121 |
ENHANCE DENTAL IMPLANT SYSTEM | DENTAL IMPLANT ACCESSORIES |
| 18 | COWELL MEDI CO., LTD. 155-4 GAMJEON-DONG SASANG-GU, BUSAN, KS 82-51-3142028 / 562-404-8466 |
ALLFIM IMPLANT SYSTEM | VARIOUS TYPES OF ALLFIM IMPLANT SYSTEMS |
| 19 | CSM KYUNG-POOK UNIVERSITY # 573-13 BOKHYUN-DONG, BUKGU DAEGU, 702-020 KS 82-53-9528261 / 440-212-4949 |
APOLONIA | ACCESSORIES OF DENTAL IMPLANT |
| 20 | DENTATUS AB JAKOBSDALSVAGEN 14-16 HAGERSTEN, SE-126 53 SW 46-854-650900 / 46-854-650900 |
MULTIPLE | ENDOSSEOUS DENTAL IMPLANT ACCESSORIES |
| 21 | DENTIUM CO., LTD. 27-5 LEUI-DONG, YEONGTONG-GU SUWON-SI, GYEONGGI-DO, 442-270 KS 82-31-2072200 / 714-895-7278 |
CCC48,CCC60,SCC48,SCC60,ZPR17,IRP17,SRS18T,STC4812,STC6012,STC4512L,STC55122 | VARIOUS TYPES OF IMPLANT, DENTAL, ENDOSSEOUS, ACCESSORIES |
| 22 | EMERY ENTERPRISES INC. 31 PETERS CANYON IRVINE, CA 92606 US 949-223-8950 / 949-223-8950 |
DYNATORQ PRECISE | TYPES OF WRENCHES AND DRIVERS |
| 23 | FALCON SURGICAL CO (PVT) LTD. WAZIRABAD RD., P.O. BOX 134 NEAR VILLAGE GOLOPHALA UGOKI SIALKOT, PK 092-523-510072 / 720-962-5412 |
MULTIPLE | VARIOUS ACCESSORIES |
| 24 | FRIADENT GMBH STEINZEUGSTRASSE POSTFACH 710261 MANNHEIM, 68229 GM 717-849-4229 / 717-849-4229 |
ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS (MULTIPLE BRANDS) | DENTAL IMPLANT ACCESSORIES |
| 25 | H & H CO. 4435 EAST AIRPORT DR., #108 ONTARIO, CA 91761 US 909-390-0373 / 909-390-0373 |
ACCESSORIES, IMPLANT, DENTAL | ACCESSORIES, IMPLANT, DENTAL ALL TYPES |
| 26 | HAGER & MEISINGER GMBH HANSEMANNSTRASSE 10 NEUSS, D-41468 GM / 303-268-5400 |
MEISINGER, BONE MANAGEMENT | ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS |
| 27 | HEEP TUNG MANUFACTORY, LTD. 26-28 AU PUI WAN ST FLAT 401-2 FO TAN IND. CTR. FO TAN, HONG KONG, CH 852-260-45625 / 650-238-9118 |
THERMOPLASTIC TEMPLATE DRILL SETS | DENTAL IMPLANT SURGICAL GUIDE |
| 28 | HI TEC IMPLANTS, LTD. 16 GALGALEI PLADA ST. HERZLIA, 46722 IS 972-995-86803 / 425-894-9621 |
MULTIPLE | ACCESSORIES, DENTAL IMPLANTS |
| 29 | INNOVA LIFE SCIENCES CORP. 60 IRONSIDE, UNIT #3 SCARBOROUGH, ONTARIO, M1X 1G4 CA 714-516-7400 / 714-516-7484 |
MULTIPLE | DENTAL IMPLANT ACCESSORIES |
| 30 | INSTITUT STRAUMANN AG PETER-MERIAN-WEG 12 BASEL, CH-4002 SZ 011-41-9651111 / 41-61-9651204 |
MULTIPLE | ENDOSSEOUS DENTAL IMPLANT ACCESSORIES |
| 31 | INSTITUT STRAUMANN SA LES CHAMPS DU CLOS 2 VILLERET, CH-2613 SZ 011-41-9651111 / 41-61-9651204 |
MULTIPLE | ENDOSSEOUS DENTAL IMPLANT ACCESSORIES |
| 32 | IVOCLAR VIVADENT AG BENDERERSTRASSE 2 SCHAAN, FL-9494 LS 716-691-2260 / 716-691-2260 |
SR VIROTAC / SR ORTHOTAC | IMPLANT ACCESSORIES |
| 33 | JEIL MEDICAL CORPORATION #702, KOLON SCIENCE VALLEY 2ND 811, GURO-DONG, GURO-GU SEOUL-CITY, KS 82-02-850 3500 / 847-374-8854 |
LINGUAL DRIVER | MANUAL DENTAL IMPLANT ACCESSORY |
| 34 | JOHN SJODING AB ROSENLUNDSGATAN 50 BOX 38075 STOCKHOLM, S-10064 SW 468-703-6900 / 468-703-6900 |
VARIOUS TYPES OF NON-STERILE DENTAL IMPLANT ACCESSORIES | VARIOUS TYPES OF NON-STERILE DENTAL IMPLANT ACCESSORIES |
| 35 | JOSEF GANTER FEINMECHANIK GMBH NIEDERESCHACHERSTRASSE 24 DAUCHINGEN, 78083 GM / 49-772-04474 |
ENDOSSEOUS DENTAL IMPLANT ACCESSORIES | ENDOSSEOUS DENTAL IMPLANT ACCESSORIES |
| 36 | KOHLER MEDIZINTECHNIK GMBH & CO. KG DANNINGEN 9 NEUHAUSEN, D-78579 GM 497-777-939530 / 497-777-939530 |
PERIOTOME, PERIOTOME HANDLE & INSERTS & OTHER IMPLANT ACCESSORIES | DENTAL IMPLANT ACCESSORIES |
| 37 | LEADER ITALIA S.R.L. VIA AQUILEJA 43/B CINISELLO BALSAMO - MI, 20092 IT 39-026-18651 / 212-289-4748 |
MULTIPLE | IMPLANT ACCESSORY COMPONENTS |
| 38 | LEONE SPA 50, VIA P. A QUARACCHI SESTO, FLORENTINO, I-50019 IT 39-055-3044620 / 807-487-9868 |
ACCESSORIES FOR SURGICAL AND PROSTHETIC DENTAL IMPLANT PROCEDURES/TAPS | ACCESSORIES, DENTAL IMPLANT |
| 39 | MATERIALISE DENTAL TECHNOLOGIELAAN 15 LEUVEN, 3001 BE 32-16-39 66 20 / 32-16-396714 |
SAFE SYSTEM COMPONENT | DRILL TUBE, IMPLANT HOLDER, IMPLANT CONTAINER, SAFE SYSTEM |
| 40 | MEGAGEN CO., LTD. 377-2 GYOCHUN-RI, JAIN-MYUN GYEONGSAN, GYEONGBUK, KS 82-53-8575770 / 562-404-8466 |
INTERMEZZO IMPLANT SYSTEM | VARIOUS TYPES INTERMEZZO IMPLANT SYSTEMS |
| 41 | MODUS SNC DI ANTONIO GIANNONE E MARTINA LAMPING VIA GALILEI 34 31059 ZERO BRANCO (TV), 31059 IT 011-39-0422485860 / 011-39-0422485860 |
ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS | VARIOUS AIDS OR LABORATORY PIECES USED IN FABRICATION OF DENTAL PROSTHESIS |
| 42 | MONDEAL MEDICAL SYSTEMS GMBH MOLTKESTR. 39 TUTTLINGEN, 78532 GM 49-746-1933214 / 858-901-4123 |
ENDOSSEOUS DENTAL IMPLANT ACCESSORIES (VARIOUS TYPES) | ENDOSSEOUS DENTAL IMPLANT ACCESSORIES |
| 43 | NEOSS, LTD. WINDSOR HOUSE, CORNWALL RD. HARROGATE, YORKSHIRE, HG1 2PW UK 44-142-3817733 / 44-142-3817733 |
NEOSS IMPLANT SYSTEM - INSTRUMENTS | SCREWDRIVERS, DRILL EXTENDERS, DIRECTION INDICATORS |
| 44 | NOBEL BIOCARE (PRODUCTION) AB DIMBOV. 2 KARLSKOGA S-691-51, SW 46-31-81-88-00 / 714-282-5074 |
ENDOSSEOUS DENTAL IMPLANT ACCESSORIES | ENDOSSEOUS DENTAL IMPLANT ACCESSORIES AND LABORATORY ACCESSORIES |
| 45 | NOBEL BIOCARE AB 15 BOHUSGATAN, P.O. BOX 5190 GOTEBORG, S-402 26 SW 46-31-81-88-00 / 714-282-5074 |
ENDOSSEOUS DENTAL IMPLANT ACCESSORIES | ENDOSSEOUS DENTAL IMPLANT ACCESSORIES AND LABORATORY ACCESSORIES |
| 46 | NOBEL BIOCARE DISTRIBUTION CENTER BV INDUSTRIAL ZONE NUMBER 7708 KOZAKKENBERG 4 BELFELD, 5951 DL NL 46-31-81-88-00 / 714-282-5074 |
ENDOSSEOUS DENTAL IMPLAMT ACCESSORIES | ENDOSSEOUS DENTAL IMPLAMT ACCESSORIES AND LABORATORY A |
| 47 | NOBEL BIOCARE USA, LLC 22715/22725 SAVI RANCH PARKWAY YORBA LINDA, CA 92887 US 46-31-81-88-00 / 714-282-5074 |
ENDOSSEOUS DENTAL IMPLANT ACCESSORIES | ENDOSSEOUS DENTAL IMPLANT ACCESSORIES AND LABORATORY ACCESSORIES |
| 48 | ORALTRONICS JULIUS-BAMBERGER-STRASSE 8 A BREMEN, 28279 GM 714-516-7400 / 714-516-7484 |
MULTIPLE | DENTAL IMPLANT ACCESSORIES |
| 49 | ORMCO CORP. 1332 SOUTH LONE HILL AVE. GLENDORA, CA 91740 US 714-516-7400 / 714-516-7484 |
MULTIPLE | DENTAL IMPLANT ACCESSORIES |
| 50 | OSSEO SCIENTIFIC, LLC 3138 VEEDER AVE. TOMS RIVER, NJ 08753 US 201-490-5421 / 201-490-5421 |
ENDOSSEOUS DENTAL IMPLANT ACCESSORIES | DENTAL IMPLANT ACCESSORIES |
| 51 | OSUNG MND CO., LTD 324, KUNHA-RI, WOLKOT-MYEON KIMPO, 415-870 KS 82-31-9875395 / 82-31-9875395 |
MULTIPLE | IMPLANT INSTRUMENT |
| 52 | QUALITY ASPIRATORS, INC. 1419 GODWIN LN. DUNCANVILLE, TX 75116 US 972-298-2669 / 972-298-2669 |
THOMMEN HD-1200 | IMPLANT HANDLE DRIVER |
| 53 | QUANTUM BIOENGINEERING, LTD. 7951 S.W. 6TH ST. PLANTATION, FL 33324 US 954-474-4707 / 954-474-4707 |
QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM | DENTAL IMPLANT ACCESSORIES & INSTRUMENTATION |
| 54 | RADIANT EXPRESS LLC 340 MAC LANE KEASBEY, NJ 08832 US 732-738-8108 / 732-738-8108 |
ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS | HAND PIECE |
| 55 | RMO, INC. 650 WEST COLFAX AVE. DENVER, CO 80204 US 303-592-8200 8217 / 303-592-8200 8206 |
DUAL TOP PLACEMENT AND REMOVAL TOOLS | IMPLANT PLACEMENT AND REMOVAL TOOLS |
| 56 | SIC INVENT AG BIRMANNSGASSE 3 BASEL, 4055 SZ 41-61-2613966 / 41-61-2613966 |
SIC PRO ACCESSORIES | ACCESSORIES FOR DENTAL IMPLANTS |
| 57 | SICAT GMBH & CO. KG BRUNNENALLEE 6 BONN, D-53177 GM 49-228-8546970 / 49-228-85469784 |
GALILEOS SURGICAL GUIDE | SURGICAL GUIDE |
| 58 | SIN SISTEMA DE IMPLANTE NACIONAL LTDA AV. PAES DE BARROS,485 MOOCA SAO PAULO, 03115-020 BR 551-121-693000 / 55-11-21693000 |
SISTEMA DE IMPLANTE NACIONAL | VARIOUS TYPES OF DENTAL, ENDOSSEOUS, IMPLANT, ACCESSORIES |
| 59 | SOADCO, S.L. AV FITER I ROSSELL 4 BIS LOCAL 2 ESCALDES-ENGORDANY, AD-700 AN 37-6-800590 / 37-6-800590 |
VARIOUS TYPES OF ACCESSORIES DENTAL IMPLANT | VARIOUS TYPES OF ACCESSORIES DENTAL IMPLANT |
| 60 | SOUTHERN IMPLANTS (PTY) LTD ONE ALBERT ROAD IRENE, GAUTENG, 0062 SF 27-12-6671046 / 27-12-6671046 |
MULTIPLE | DENTAL IMPLANT ACCESSORIES |
| 61 | SOUTHERN IMPLANTS, INC. 11250 WAPLES MILL ROAD, SUITE 320 FAIRFAX, VA 22030 US 703-293-2900 / 703-293-2900 |
NSI HEXED AND NON-HEXED IMPLANT SYSTEM | ENDOSSEOUS DENTAL IMPLANT ACCESSORIES |
| 62 | STORZ AM MARK GMBH EMMINGER STR. 39 EMMINGEN-LIPTINGEN, 78576 GM 49-746-5926030 / 49-746-5926030 |
MULTIPLE | DIFFERENT ACCESSORIES FOR DENTAL IMPLANTOLOGY |
| 63 | STRAUMANN MANUFACTURING, INC. 60 MINUTEMAN RD. ANDOVER, MA 01810 US 011-41-9651111 / 978-747-2575 |
STRAUMANN DENTAL IMPLANT SYSTEM | IMPLANT ANALOG |
| 64 | THOMMEN MEDICAL, AG NECKARSULMSTRASSE 28 GRENCHEN, CH-2540 SZ 41- 61-965 9020 / 41-061-965 9036 |
MULTIPLE | DENTAL IMPLANT INSTRUMENTS AND ACCESSORIES |
| 65 | THOMMEN MEDICAL, AG HAUPTSTRASSE 26D WALDENBURG, CH-4437 SZ 41- 61-965 9020 / 41-061-9659036 |
MULTIPLE | DENTAL IMPLANT INSTRUMENTS AND ACCESSORIES |
| 66 | VERICOM CO., LTD. #606,5TH DONGYOUNG VENTURESTEL 199-32, ANYANG 7-DONG,MANAN-GU ANYANG-SI, GYEONGGI-DO, 430-817 KS 82-31-441-2881 / 82-31-441-2881 |
DENFIL ETCHANT | ETCHANT |
| 67 | VERIO DENTAL CO. LTD. 3278 WEST 37TH AVENUE VANCOUVER,B.C., V6N 2V4 CA 604-437-3253 / 604-437-3253 |
MULTIPLE | DENTAL IMPLANT DEVICES |
| 68 | W & H DENTALWERK BUERMOOS GMBH 53 IGNAZ-GLASER-STRASSE BUERMOOS, 5111 AU 43-627-4623658 / 43-627-46236397 |
IDC IMPLANTOLOGY DISTANCE CONTROL | ENDOSSEOUS DENTAL IMPLANT ACCESSORIES |
| 69 | ZIMMER DENTAL INC. 1900 ASTON AVE. CARLSBAD, CA 92008 US 800-613-6131 / 760-929-4107 |
MULTIPLE | DENTAL IMPLANT ACCESSORIES |
| 70 | ZOLL DENTAL 7450 NORTH NATCHEZ AVE. NILES, IL 60714 US 847-647-1819 / 847-647-1819 |
ACCESSORIES, IMPLANT, DENTAL | VARIOUS TYPES AND DENTAL IMPLANT ACCESSORIES |
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