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S-FILE, K-FILE,K-REAMER, NITI-FILE-MANUAL & ENGINE
 Request for Information Form |
 Contact Information
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| Company Name | DIRECTA AB |
| Address | PO BOX 723
FINVIDS VAG 8 |
| City, State, Zip | UPPLANDS VAESBY, |
| Country | SW |
| FDA Owner/Operator Phone | +46--8--50650575 |
| FDA Medical Specialty Code | DE - Dental |
| FDA Product Code | EKS |
| FDA Classification Name | FILE, PULP CANAL, ENDODONTIC |
| FDA Device Classification Code | General Controls |
| FDA Regulation Number | 872.4565 |
| FDA Common Generic Name | S-FILE, K-FILE,H-FILE, K-REAMER, ENDODONTIC FILES |
| FDA Proprietary Device Name | S-FILE, K-FILE,K-REAMER, NITI-FILE-MANUAL & ENGINE |
| FDA Owner / Operator Number | 9004750 |
| FDA Owner / Operator Name | DIRECTA AB |
| FDA Establishment Registration Number | 8030938 |
| FDA Registered Establishment Name | DIRECTA AB |
| FDA Operation Code(s) |
MM - Manufacturer |
| FDA Listing Date | 06-26-02 |
| FDA Listing Status Code | Active |
| Differentiation | N/A |
| Keywords | N/A |
| Description | N/A |
| Brochure | N/A |
| Product Website | N/A |
Competitors of DIRECTA AB
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 | AESCULAP, INC. 3773 CORPORATE PKWY. CENTER VALLEY, PA 18034 US 800-258-1946 / 610-984-9074 |
VARIOUS | VARIOUS |
| 2 | AMC GENERAL, INC. 800 KING GEORGE BLVD. SAVANNAH, GA 31419 US 800-535-6638 / 912-925-8525 5481 |
RACE ENDODONTIC FILE | ENDODONTIC FILE |
| 3 | BRASSELER USA I, L.P. ONE BRASSELER BLVD. SAVANNAH, GA 31419 US 912-925-8525 / 912-925-8525 5481 |
MULTIPLE | ENDODONTIC FILES |
| 4 | BUSCH & CO. KG UNTERKALTENBACH 17-27 ENGELSKIRCHEN, 51766 GM 011-49-2263 860 / 202-293-5555 |
BUSCH & CO. KG | DENTAL HAND INSTRUMENT |
| 5 | CHARLES B. SCHWED CO., INC. 124-02 METROPOLITAN AVE. KEW GARDENS, NY 11415 US 718-441-0526 / 718-441-0526 |
SCHWED MAXIFLEX NITI K FILES | ENDODONTIC K FILES |
| 6 | D&S DENTAL, LLC 3111 HANOVER ROAD JOHNSON CITY, TN 37604 US 423-928-1299 / 423-928-1299 |
D&S DENTAL, LLC | HAND FILES, ENDODONTIC |
| 7 | DENTAL POWER, INC. 24422 DEL PRADO #11 P.O. BOX 3810 DANA POINT, CA 92629 US 800-497-6784 / 800-487-6784 |
NITI ENGINE REAMERS | ENDODONTIC REAMER |
| 8 | DENTAL USA, INC. 5005 MCCULLOM LAKE RD. MCHENRY, IL 60050 US 815-363-8003 / 815-363-8003 |
MULTIPLE | FILE |
| 9 | DENTSPLY TULSA DENTAL SPECIALTIES 5100 E. SKELLY DR. SUITE 300 TULSA, OK 74135 US 717-849-4229 / 717-845-7511 |
MULTIPLE | FILES AND REAMERS |
| 10 | DENTSPLY TULSA DENTAL SPECIALTIES 608 ROLLING HILLS DR. JOHNSON CITY, TN 37604 US 717-849-4229 / 717-845-7511 |
MULTIPLE | FILES AND REAMERS |
| 11 | DIADENT GROUP INTL., INC. 11-3871 NORTH FRASER WAY BURNABY, B.C., V5J 5G6 CA 877-342-3368 / 604-451-8851 |
DIADENT | H-FILE,K-FILE |
| 12 | DURANGO DENTAL SUPPLY, INC. 6726 FAIRVIEW TERRACE BRADENTON, FL 34203 US 800-377-4080 / 941-753-5078 |
MULTIPLE | VARIOUS |
| 13 | ESSENTIAL DENTAL SYSTEMS, INC. 89 LEUNING ST. SOUTH HACKENSACK, NJ 07606 US 201-487-9090 / 201-487-9090 |
EZ-FILL SAFESIDER | ENDODONTIC HAND FILE INSTRUMENT |
| 14 | EURODENT INC. 2500 NE 207TH TERRACE MIAMI, FL 33180 US 305-305-0645 / 305-305-0645 |
FILE, PULP CANAL, ENDODONTIC~DENTAL | FILE, PULP CANAL, ENDODONTIC~DENTAL |
| 15 | FFDM-PNEUMAT 78-80 AV DE LA PROSPECTIVE BOURGES CEDEX, 18020 FR 33-248-23 27 37 / 33-248-23 27 37 |
K-FILE; HEDSTROM FILE | K-FILES & HEDSTROM FILES, VARIOUS SIZES |
| 16 | FRIADENT GMBH STEINZEUGSTRASSE POSTFACH 710261 MANNHEIM, 68229 GM 717-849-4229 / 717-849-4229 |
DENTAL HAND INSTRUMENTS (MULTIPLE BRANDS) | VARIOUS TYPES OF DENTAL HAND INSTRUMENTS |
| 17 | GEBR. BRASSELER GMBH & CO. KG TROPHAGENER WEG 25 POSTFACH 160 LEMGO, D-32631 GM 495-261-701467 / 495-261-701467 |
KOBRA ENDODONTIC ROOT CANAL FILE | ENDODONTIC ROOT CANAL FILE |
| 18 | GUIDANCE ENDODONTICS, LLC 7520 MONTGOMERY BOULEVARD, SUITE E-1 ALBUQUERQUE, NM 87109 US 505-797-1212 / 703-206-0906 |
GUIDANCE ROTARY SYSTEM | ENDODONTIC PULP CANAL FILE |
| 19 | HAGER & MEISINGER GMBH HANSEMANNSTRASSE 10 NEUSS, D-41468 GM / 303-268-5400 |
MEISINGER | FILE, PULP CANAL, ENDODONTIC |
| 20 | HAGER & WERKEN GMBH ACKERSTRASSE 1 DUISBURG, D-47269 GM / 813-926-7474 |
PREPOMETER | MEASURING PULP |
| 21 | HANGZHOU DENTECN MEDICAL APPARATUS CO., LTD. HONGJIAMEN JIANGCUN XIHU DISTRICT HANGZHOU, ZHEJIANG, 310013 CH 86-571-88991960 / 86-130-67942741 |
MULTIPLE | K-FILE, H-FILE, SPREADER, PLUGGER, PROTAPER |
| 22 | HU-FRIEDY MFG. CO.,INC. 3232 NORTH ROCKWELL ST. CHICAGO, IL 60618 US 773-975-6100 / 773-975-6100 |
MULTIPLE | FILES, ENDODONTIC |
| 23 | INFINITY BUSINESS INTERNATIONAL 803 MARLEEN ST. HOUSTON, TX 77034 US 832-476-3849 / 832-476-3849 |
MULTIPLE | VARIOUS TYPES OF ENDODONTIC PULP CANAL FILES |
| 24 | INTERNATIONAL PLASTICS, LLC 4965 N. CAMPBELL DR. MENOMONEE FALLS, WI 53051 US 262-781-2270 / 262-781-2270 |
F-FILE | ROTARY ENDODONTIC FILE |
| 25 | J. MORITA MFG. CORP. 680 HIGASHIHAMA MINAMI-CHO, FUSHIMI-KU KYOTO, 612-8533 JA 81-75-605 2300 / 202-783-5070 |
VISIONER 21-A | ENDODONTIC FILE |
| 26 | JIANGYIN BEITE NEW DATUM CO., LTD. JIANGYIN HUANGTANG INDUSTRIAL DISTRICT JIANG YIN CITY, JIANGSU, 214413 CH 86-510-86538787 / 86-510-86538787 |
ENDODONTIC PULP CANAL FILE | K FILE, HEDSTROM FILE, REAMER FILE |
| 27 | JOTA AG HIRSHENSPRUNGSTRASSE 2 RUTHI, SG, 9464 SZ 41-717-677999 / 41-717-677974 |
JOTA | DENTAL HAND INSTRUMENT |
| 28 | JS DENTAL MFG., INC. 196 NORTH SALEM RD. RIDGEFIELD, CT 06877 US 203-438-8832 / 203-438-8832 |
S-FILE, ENGINE S-FILE | S-FILE, ENGINE S-FILE |
| 29 | KARL HAMMACHER GMBH STEINENDORFERSTR. 27 SOLINGEN, D-42699 GM / 212-262-500 |
MULTIPLE | VARIOUS TYPES OF PULP CANAL FILES |
| 30 | KERR CORP. 28200 WICK RD. ROMULUS, MI 48174 US 714-516-7400 / 714-516-7484 |
MULTIPLE | PULP CANAL FILE |
| 31 | MAILLEFER INSTRUMENTS HOLDING SA CH. DU VERGER 3 BALLAIGUES, CH-1338 SZ 717-849-4229 / 717-849-4229 |
MULTIPLE | FILES AND REAMERS |
| 32 | MANI, INC. (TAKANEZAWA FACILITY) 743 NAKAAKUTSU TAKANEZAWA-MACHI TOCHIGI-KEN, 329-1234 JA 81-028-6753311 / 410-793-0484 |
K-FILES, HEDSTROM FILES | K-FILES, HEDSTROM FILES |
| 33 | MAXIMUM DENTAL, INC. 600 MEADOWLANDS PARKWAY SUITE 269 SECAUCUS, NJ 07094 US 800-629-6294 / 631-245-2176 |
NITI MAX | ENDODONTIC PULP CANAL FILE |
| 34 | MEDECO INTL., INC. 5535 N.W. 74TH AVENUE MIAMI, FL 33166 US 305-888-6410 / 305-888-6410 |
ENDOTEK MULTIPLE K-FILES AND H-FILES | MULTIPLE ENDO FILES |
| 35 | MICRO-MEGA SOCIETE ANONYME 5-12 RUE DU TUNNEL CEDEX BESANCON, 25006 FR / 33-381-544229 |
HERO 642 | FILE |
| 36 | MILTEX, INC. 589 DAVIES DRIVE YORK, PA 17402 US 609-275-0500 / 717-840-3409 |
MULTIPLE | VARIOUS ENGINE-DRIVEN ENDODONTIC INSTRUMENTS |
| 37 | ORMCO CORP. 1332 SOUTH LONE HILL AVE. GLENDORA, CA 91740 US 714-516-7400 / 714-516-7484 |
MULTIPLE | ENDODONTIC FILES |
| 38 | ORMEX, S.A. DE C.V. CALLE 21, #1103, AMPLIACION CIUDAD IND. YUCATAN UMAN, MX 714-516-7400 / 714-516-7484 |
MULTIPLE | ENDODONTIC FILES |
| 39 | PATTERSON DENTAL SUPPLY, INC. 1031 MENDOTA HEIGHTS RD. ST. PAUL, MN 55120 US 651-686-1600 / 651-686-1600 |
MULTIPLE | VARIOUS SIZES OF ENDODONTIC PULP CANAL FILES |
| 40 | PLASTIC ENDO, LLC 318 HALF DAY RD. #247 BUFFALO GROVE, IL 60089 US 866-752-3636 / 866-752-3636 |
FILE, PULP CANAL, ENDODONTIC | DENTAL HAND INSTRUMENT |
| 41 | PRODONTA S.A. 3 RUE DE LA MAIRIE GENEVA, 1207 SZ 41-22-7358760 |
STOPAPEX | STOPAPEX |
| 42 | PULPDENT CORPORATION 80 OAKLAND ST. P.O. BOX 780 WATERTOWN, MA 02471 US 617-926-6666 / 617-926-6666 |
EDTA, 17% SOLUTION | 17% EDTA SOLUTION |
| 43 | REDENT-NOVA LTD. 15 HATA'ASIA STREET RA'ANANA, POB 4159, 43000 IS 972-974-45130 70 / 972-974-45130 70 |
SELF ADJUSTABLE FILE (SAF) | ENDODONTIC FILES |
| 44 | SENDOLINE AB TILLVERKARVAGEN 6 P.O. BOX 7037 TABY, S-187 11 SW 46-844-58830 / 46-844-58830 |
FILE, PULP CANAL, ENDODONTIC (MULTIPLE BRANDS) | VARIOUS TYPES OF ENDODONTIC FILES |
| 45 | SPECIAL PRODUCTS, INC. 2540 GREENWOOD DR. KISSIMMEE, FL 34744 US 407-344-0550 / 407-344-0550 |
FINE-CUT FILES AND ADAPTORS | FILE SYSTEM |
| 46 | STORZ AM MARK GMBH EMMINGER STR. 39 EMMINGEN-LIPTINGEN, 78576 GM 49-746-5926030 / 49-746-5926030 |
MULTIPLE | TYPES OF ENDODONTIC PULP CANAL FILES |
| 47 | SUPERLINE TECHNOLOGY CO., LTD. 3/F., 3RD BLDG., MEIJIN IND. PARK, QIAOXING ROAD NANSHAN SHENZHEN, SHENZHEN, 518053 CH 86-755-26756296 / 805-522-6223 |
ENDODONTIC PULP CANAL FILE | ENDODONTIC CANAL FILE |
| 48 | ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH SOUTH JORDAN, UT 84095 US 801-572-4200 / 800-552-5512 4323 |
CHLORCID | DISINFECTING SOLUTION |
| 49 | UNITED DENTAL MFG., INC. 608 ROLLING HILLS DR. JOHNSON CITY, TN 37604 US 717-849-4229 / 717-845-7511 |
MULTIPLE | ENDODONTIC FILES |
| 50 | VDW GMBH BAYERWALDSTRASSE 15 MUNICH, 81737 GM 717-849-4229 / 717-849-4229 |
MULTIPLE | ENDODONTIC FILES |
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