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| Company Name | COLTENE/WHALEDENT INC. |
| Address | 235 ASCOT PARKWAY |
| City, State, Zip | CUYAHOGA FALLS, OH 44223 |
| Country | US |
| FDA Owner/Operator Phone | 41-71-987-1010 |
| FDA Medical Specialty Code | DE - Dental |
| FDA Product Code | EKM |
| FDA Classification Name | GUTTA-PERCHA |
| FDA Device Classification Code | General Controls |
| FDA Regulation Number | 872.3850 |
| FDA Common Generic Name | GUTTA PERCHA |
| FDA Proprietary Device Name | MULTIPLE |
| FDA Owner / Operator Number | 9089944 |
| FDA Owner / Operator Name | MEDISIZE HOLDING AG |
| FDA Establishment Registration Number | 2416455 |
| FDA Registered Establishment Name | COLTENE/WHALEDENT INC. |
| FDA Operation Code(s) |
MM - Manufacturer |
| FDA Listing Date | 09-18-03 |
| FDA Listing Status Code | Active |
| Differentiation | N/A |
| Keywords | N/A |
| Description | N/A |
| Brochure | N/A |
| Product Website | N/A |
Competitors of COLTENE/WHALEDENT INC.
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 | ACEONEDENT KOREA INDUSTRIAL CO. TECHNO-PARK 103-606 264 SAMJUNG-DONG OJUNG-KU BUCHUN-SI, KYUNGGI-DO, 421-150 KS 82--32--327-2123 / 757-224-0177 |
ACEONE-ENDO | VARIOUS SIZES OF GUTTA PERCHA POINTS |
| 2 | ASEPTICO, INC. 8333 216TH ST., S.E. WOODINVILLE, WA 98072 US 425-487-3157 / 425-487-3157 |
AEU-35 | GUTTA PERCHA DELIVERY SYSTEM |
| 3 | BRASSELER USA I, L.P. ONE BRASSELER BLVD. SAVANNAH, GA 31419 US 912-925-8525 / 912-925-8525 5481 |
BRASSELER GUTTA PERCHA | GUTTA PERCHA |
| 4 | CHINA SHENZHEN HEXING CHEMICAL MACHINERY CO. LTD. YONG FENG RD., BAI SHI SHA DISTRICT, FU YONG TOWN SHENZHEN GUANGDONG, CH / 852-288-0 9129 |
MULTIPLE | GUTTAPERCHA POINTS, ENDODONTIC |
| 5 | CMS-DENTAL APS WILDERSGADE 55 COPENHAGEN, DK-1408 DA 453-257-3000 / 405-843-7313 |
MULTIPLE | VARIOUS |
| 6 | COLTENE/WHALEDENT GMBH & CO. KG RAIFFEISENSTRASSE 30 LANGENAU, D-89129 GM 41-71-7575300 / 49-734-5805-122 |
MULTIPLE | ROOT CANAL FILLING MATERIAL |
| 7 | DENS N DENTE DENTAL SUPPLIES 620 ALDEN ROAD, UNIT 107 MARKHAM, L3R 9R7 CA 866-449-9998 / 866-449-9998 |
MULTIPLE | GUTTA PERCHA PAPER POINTS |
| 8 | DENTONICS, INC. 2833 TOPHILL RD. MONROE, NC 28110 US 704-238-0245 / 704-238-0245 |
MASTER-DENT GUTTA-PERCHA | GUTTA-PERCHA |
| 9 | DENTSPLY BRAZIL RUA ALICE HERVE 86, BINGEN PETROPOLIS, R.J., 25665-010 BR 717-849-4229 / 717-849-4229 |
MULTIPLE | GUTTA PERCHA AND ACCESSORIES |
| 10 | DENTSPLY DENTAL (TIANJIN) CO., LTD. 1/F., BLOCK C, TEDA INTL. INCUBATOR CENTRE,NO.5, TIANJIN TIANJIN ECONOMIC DVLP AREA, 300457 CH 717-849-4229 / 717-845-7511 |
MULTIPLE | GUTTA PERCHA |
| 11 | DENTSPLY DETREY-DEDENT DETREY STRASSE 1 KONSTANZ, D-78467 GM 717-849-4229 / 717-849-4229 |
GUTTA PERCHA POINTS | |
| 12 | DENTSPLY TULSA DENTAL SPECIALTIES 608 ROLLING HILLS DR. JOHNSON CITY, TN 37604 US 717-849-4229 / 717-845-7511 |
MULTIPLE | GUTTA-PERCHA AND ACCESSORIES |
| 13 | DIADENT GROUP INTERNATIONAL 19-9 SONG-JUNG DONG HEUNGDUKGU CHONGJU CITY,, 360-600 KS 82-43-2662315 / 82-43-2662315 |
GUTTA PERCHA POINTS | VARIOUS SIZES OF GUTTA POINTS |
| 14 | DIADENT GROUP INTL., INC. 11-3871 NORTH FRASER WAY BURNABY, B.C., V5J 5G6 CA 877-342-3368 / 604-451-8851 |
DIADENT | GUTTA PERCHA POINTS |
| 15 | DIRECTA AB PO BOX 723 FINVIDS VAG 8 UPPLANDS VAESBY, 194 27 SW +46--8--50650575 / 46-8-50650582 |
G-P POINTS | GUTTA-PERCHA POINTS |
| 16 | DISCUS DENTAL, LLC 8550 HIGUERA ST. CULVER CITY, CA 90232 US 310-845-8200 / 310-845-8345 |
GUTTA PERCHA | GUTTA PERCHA |
| 17 | DURANGO DENTAL SUPPLY, INC. 6726 FAIRVIEW TERRACE BRADENTON, FL 34203 US 800-377-4080 / 941-753-5078 |
PRIMARY OBTURATORS | GUTTA |
| 18 | ENDODENT, INC. 851 MERIDIAN ST. DUARTE, CA 91010 US 41-71-7575300 / 626-359-5715 |
ENDODENT GUTTA-PERCHA | GUTTA-PERCHA |
| 19 | ENDOTWINN B.V. DANZIGERKADE 17 AMSTERDAM NH, 1013 AP NL 31-20-4867571 / 31-20-4867571 |
ENDOTWINN, DOWNPAK | DENTAL INSTRUMENT HEATER |
| 20 | ESSENTIAL DENTAL SYSTEMS, INC. 89 LEUNING ST. SOUTH HACKENSACK, NJ 07606 US 201-487-9090 / 201-487-9090 |
MULTIPLE | GUTTA-PERCHA |
| 21 | FULU DENTAL MATERIAL FACTORY XILUJIAO VILLAGE, PING GU COUNTY BEIJING, CH / 717-845-7511 4229 |
MULTIPLE | GUTTA PERCHA POINTS |
| 22 | FUTURE DENTAL TECHNOLOGIES, INC. 26398 DEERE CT., SUITE 105 MURRIETA, CA 92562 US 909-894-4203 / 909-894-4203 |
MULTIPLE; MICROSEAL BY ANALYTIC NH 110/220 (110 &220V VERSION) | VARIOUS; GUTTA-PERCHA HEATER (ACCESSORY) |
| 23 | GAPADENT CO., LTD. DADUZHUANG VILLAGE XINKOU TOWN, XIQING DISTRICT TIANJIN, 300380 CH 86-22-87993921 / 86-22-87993921 |
GAPA | GUTTA PERCHA POINTS |
| 24 | HEALTHDENT TECHNOLOGY, LTD. LI YUAN LI, # 7-1503 CHAO YANG DISTRICT BEIJING, 100025 CH 86-10-58625580 / 661-942-4615 |
GUTTA-PERCHA | GUTTA-PERCHA |
| 25 | HU-FRIEDY MFG.CO., INC., ZWEIGNIEDERLASSUNG DEUTSC RUDOLF-DIESEL-STR. 8 LEIMEN, D69181 GM 773-975-6100 / 773-975-3975 3605 |
HU-FRIEDY DOWNPAK | GUTTA PERCHA ACCESSORY |
| 26 | JINGXIN DENTAL MATERIAL FACTORY TOU TUN VILLAGE, XINAN TOWN, BAXIAN HEBEI PROVINCE, CH / 717-845-7511 4229 |
MULTIPLE | GUTTA PERCHA POINTS |
| 27 | JS DENTAL MFG., INC. 196 NORTH SALEM RD. RIDGEFIELD, CT 06877 US 203-438-8832 / 203-438-8832 |
QUICK-FILL, GUTTA PERCHA POINTS | GUTTA PERCHA POINTS |
| 28 | KERR CORP. 28200 WICK RD. ROMULUS, MI 48174 US 714-516-7400 / 714-516-7484 |
MULTIPLE | GUTTA PERCHA |
| 29 | MAILLEFER INSTRUMENTS HOLDING SA CH. DU VERGER 3 BALLAIGUES, CH-1338 SZ 717-849-4229 / 717-849-4229 |
GUTTA-PERCHA (MULTIPLE BRANDS) | GUTTA-PERCHA AND ACCESSORIES |
| 30 | MEDECO INTL., INC. 5535 N.W. 74TH AVENUE MIAMI, FL 33166 US 305-888-6410 / 305-888-6410 |
ENDOTEK MULTIPLE GUTTA PERCHA | GUTTA PERCHA |
| 31 | META BIOMED CO., LTD. 414-12 MO CHOONG DONG CHONG JU CITY, CHOONG CHONG BUK DO, KS 011-82-432721610 / 718-639-7460 |
CARLES GUTTAPERCHA POINTS | GUTTAPERCHA POINTS |
| 32 | MILTEX, INC. 589 DAVIES DRIVE YORK, PA 17402 US 609-275-0500 / 717-840-3409 |
MULTIPLE | VARIOUS GUTTA PERCHA POINTS AND CONES AND ACCESSORIES |
| 33 | NEW STETIC CARRERA 53, NO. 50-09 GUARNE, ANTIOQUIA, CO 574-550-0000 / 561-278-8808 |
MULTIPLE | GUTTA-PERCHA |
| 34 | ORMCO CORP. 1332 SOUTH LONE HILL AVE. GLENDORA, CA 91740 US 714-516-7400 / 714-516-7484 |
MULTIPLE | GUTTA PERCHA |
| 35 | PATTERSON DENTAL SUPPLY, INC. 1031 MENDOTA HEIGHTS RD. ST. PAUL, MN 55120 US 651-686-1600 / 651-686-1600 |
GUTTA-PERCHA, MULTIPLE ITEMS | GUTTA-PERCHA POINTS |
| 36 | PEARL DENT CO., LTD. NO.15B STREET NO.13 TAN BINH INDUSTRIAL PARK HOCHIMINH CITY, VM 84-8-815 2866 / 848-815-2866 |
PEARL-ENDOPIA | GUTTA PERCHA POINT |
| 37 | PENTRON CLINICAL TECHNOLOGIES 68-70 NORTH PLAINS INDUSTRIAL ROAD WALLINGFORD, CT 06492 US 203-265-7397 231 / 203-265-7397 280 |
EPIPHANY | GUTTA-PERCHA |
| 38 | PRECISE DENTAL INTERNACIONAL S.A.C.V. 925 PARQUE CUZIN BELENES NORTE ZAPOPAN, JALISCO, MX 818-992-5333 / 818-992-1888 |
GUTTA-PERCHA POINTS | GUTTA-PERCHA POINTS |
| 39 | PRODUITS DENTAIRES SA 18, RUE DES BOSQUETS VEVEY (SUISSE), CH-1800 SZ 41-21-9212631 / 41-219-212631 |
"PD" GUTTA PERCHA POINTS | PULP CANAL GUTTA PERCHA POINTS, ENDODONTIC |
| 40 | RITE-DENT MANUFACTURING CORP. 3750 EAST 10TH CT. HIALEAH, FL 33013 US 305-693-8626 / 305-693-8626 |
MULTIPLE TYPES OF GUTTA PERCHA | VARIOUS TYPES OF GUTTA PERCHA |
| 41 | SENDOLINE AB TILLVERKARVAGEN 6 P.O. BOX 7037 TABY, S-187 11 SW 46-844-58830 / 46-844-58830 |
GUTTA PERCHA POINTS | GUTTA PERCHA POINTS |
| 42 | SHANGHAI PROMINENT WESTERN DENTAL BIOTECH DEVELOP 812 LU JIA BANG RD., #406 SHANGHAI, 200011 CH 86-21-63164398 / 203-294-9350 |
GUTTA PERCHA POINTS, VARIOUS SIZES | CUTTA PERCHA POINTS W/VARIOUS SIZES; ACCESSORY POINTS |
| 43 | SHANGHAI XING YU MEDICAL EQUIPMENT CO., LTD. 909 FA HUA ZHEN RD SHANGHAI, 200051 CH 86-21-56683134 / 86-21-56683134 |
GUTTA-PERCHA POINT | DENTAL ROOT CANAL GUTTA PERCHA POINT |
| 44 | SOFT-CORE TEXAS, INC. 800 W. SANDY LAKE RD. SUITE 100 COPPELL, TX 75019 US 469-635-6100 / 469-635-6100 |
SOFT-CORE ENDODONTIC OBTURATOR | GUTTA PERCHA OBTURATOR |
| 45 | SPIDENT CO., LTD. 312, 151B-6L NAMDONGGONGDAN INCHEON, 405-821 KS 82-32-8210071 / 516-482-9001 |
GUTTA PERCHA POINTS, VARIOUS SIZES | GUTTA PERCHA POINT |
| 46 | SUNDENT SC POLAND PULASKIEGO 25 CZESTOCHOWA, 42-200 PL 483-436-51696 / 757-224-0177 |
GUTTA PERCHA | GUTTA PERCHA |
| 47 | SURE DENT CORP. # 809 SUNTECH-CITY II, 307-2, SANGDAEWON-DONG, JUNGWON-GU SEONGNAM-SI, GYEONGGI-DO, 462-806 KS 82-31-7374720 / 82-31-7374720 |
GUTTA-PERCHA POINTS | GUTTA-PERCHA POINTS |
| 48 | TANARIMAN INDUSTRIAL LTDA. 112, AV. EDUARDO RIBEIRO MANACAPURU/AMAZOMAS, 69400-000 BR 55-92-635-9437 / 55-92-635-9438 |
CARLES GUTTAPERCHA POINTS | GUTTAPERCHA POINTS |
| 49 | THE HATAKEYAMA DENTAL MFG. CO., LTD. 1-22-10, HARIMACHO ABENO-KU OSAKA, 5450022 JA 816-662-26361 / 816-662-26361 |
MULTIPLE | VARIOUS TYPES OF GUTTA-PERCHA |
| 50 | TIANJIN DIADENT CO., LTD. JIAZHUANGZI CUN, DASI ZHEN XIQING QU TIANJIN CITY, CH 86-022-23970744 / 86-022-23970744 |
DIADENT | GUTTA PERCHA POINTS |
| 51 | UNICEP PACKAGING, INC. 1702 INDUSTRIAL DR. SANDPOINT, ID 83864 US 208-265-2482 / 208-265-2482 |
MULTIPLE | VARIOUS CHELATING CLEANSER FOR ENDODONTICS |
| 52 | UNITED DENTAL MFG., INC. 608 ROLLING HILLS DR. JOHNSON CITY, TN 37604 US 717-849-4229 / 717-845-7511 |
MULTIPLE | GUTTA PERCHA OR ENDODONTIC POINTS |
| 53 | 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 |
EAZI-ENDO GUTTA PERCHA POINT | VARIOUS SIZES OF GUTTA PERCHA POINTS |
| 54 | VERIO DENTAL CO. LTD. 3278 WEST 37TH AVENUE VANCOUVER,B.C., V6N 2V4 CA 604-437-3253 / 604-437-3253 |
MULTIPLE | GUTTA PERCHA POINTS |
| 55 | WES RESEARCH 11132 S. LOWE CHICAGO, IL 60628 US 773-568-4022 / 773-568-4022 |
INSURA-SIL | GUTTA-PERCHA POINTS |
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