File, Pulp Canal, Endodontic
Regulation 872.4565
0510(k)s in 12 months (31 all time)
0recalls in 12 months (3 all time)
0recalls that name a 510(k)
Top companies in EKS
| Company | 510(k)s | Recalls |
|---|---|---|
| Union Broach, Div. Moyco Industries, Inc. | 4 | 0 |
| Miltex, Inc. | 2 | 0 |
| Ormco Corp. | 1 | 1 |
| Tycom Dental | 2 | 0 |
| United Dental Mfg., Inc. | 2 | 0 |
| A Company, Inc. | 1 | 0 |
| Angiosystems, Inc. | 1 | 0 |
| C & S Microinstruments , Ltd. | 1 | 0 |
| Coltene, Inc. | 1 | 0 |
| Dental Power, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 13, 2006 | K062856 | TF ROTARY NICKEL TITANIUM FILE Ormco Corp. | EKS |
| Mar 28, 2001 | K004031 | NT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILES Dental Power, Inc. | EKS |
| May 22, 1997 | K971319 | NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILES Tycom Dental | EKS |
| May 16, 1997 | K970649 | HERO 642 Micro-Mega, FR | EKS |
| Jun 4, 1996 | K962031 | QUANTEC SERIES 2000 ENDODONTIC FILES Tycom Dental | EKS |
| Sep 28, 1995 | K953604 | SHAPING HEDSTROM N.T. Sybron Dental Specialties, Inc. | EKS |
| Jan 3, 1994 | K935542 | NICKEL-TITANIUM K-TYPE FILE Union Broach, Div. Moyco Industries, Inc. | EKS |
| Nov 4, 1993 | K932529 | LIGHTSPEED DENTAL HAND INSTRUMENT Lightspeed Endodontics | EKS |
| Oct 20, 1993 | K933582 | PROFILE SERIES 29 FILES Tulsa Dental Products, Ltd. | EKS |
| Apr 3, 1991 | K902018 | DENTAURUM CERAMIC DEBONDING UNIT Dentauraum, Inc. | EKS |
| Mar 5, 1991 | K905640 | SOLID CORE GUTTA PERCHA CARRIER The Hygenic Corp. | EKS |
| Mar 5, 1991 | K905461 | PROCEDURE KIT/ROUTINE DENTAL PROCEDURES Angiosystems, Inc. | EKS |
| Aug 14, 1990 | K901037 | VISIONER 21-A J. Morita USA, Inc. | EKS |
| May 31, 1990 | K897195 | A-COMPANY ELECTROTHERMAL DEBONDING DEVICE (ETD) A Company, Inc. | EKS |
| Oct 24, 1989 | K883418 | DE-BOND 200 Scheu-Dental | EKS |
| Sep 15, 1989 | K892861 | DENTAL PIK U.S. Dentek Corp. | EKS |
| May 24, 1989 | K892894 | S-FILE, S-FINDER, S-ENGINE FILE Svenska Dental Instruments AB, SE | EKS |
| Oct 27, 1987 | K873671 | COLTENE PRESIDENT JET IMPRESSION MATERIALS SYSTEM Coltene, Inc. | EKS |
| Feb 27, 1987 | K864976 | SOLUSET CALCIUM DEMINERALIZING SOLUTION Endo Technic Corp. | EKS |
| Feb 19, 1987 | K870177 | ENDOBRUSH C & S Microinstruments , Ltd., CA | EKS |
| Feb 19, 1987 | K864922 | DENTAL HANDPIECES AND ATTACHMENT E&D Dental Manufacturing Co. | EKS |
| Mar 6, 1986 | K855136 | FLEXOR FLEXIBLE ROANE TIP ENDODONTIC FILE Union Broach, Div. Moyco Industries, Inc. | EKS |
| Dec 28, 1982 | K823685 | FILE TYPE H (HEDSTROEM) ENDODONTIC United Dental Mfg., Inc. | EKS |
| Dec 28, 1982 | K823684 | FILE TYPE K ENDODONTIC United Dental Mfg., Inc. | EKS |
| Nov 24, 1982 | K823318 | DENTAL INSTRUMENTS - EXCAVATORS Miltex, Inc. | EKS |
| Nov 24, 1982 | K823316 | DENTAL INSTRUMENTS - FILES Miltex, Inc. | EKS |
| Sep 28, 1982 | K822622 | ROOT CANAL FILES, TYPE H (HEDSTROM Union Broach, Div. Moyco Industries, Inc. | EKS |
| Sep 28, 1982 | K822621 | ROOT CANAL FILES, TYPE K Union Broach, Div. Moyco Industries, Inc. | EKS |
| Oct 23, 1981 | K812692 | FILES & REAMERS Miltex Instrument Co. | EKS |
| Aug 25, 1981 | K812260 | DYNA TRAK ENDODONTIC PREP. INSTRUMENT Inventive Technology Int'L., Inc. | EKS |
| Feb 19, 1980 | K800293 | FILE, PULP CANAL Ipco Corp. | EKS |
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