EKS · File, Pulp Canal, Endodontic
Dental · 21 CFR 872.4565 · Class 1
Overview
| Product Code | EKS |
|---|---|
| Device Name | File, Pulp Canal, Endodontic |
| Regulation | 21 CFR 872.4565 |
| Device Class | Class 1 |
| Review Panel | Dental |
Identification
A dental hand instrument is a hand-held device intended to perform various tasks in general dentistry and oral surgery procedures. The device includes the operative burnisher, operative amalgam carrier, operative dental amalgam carver, surgical bone chisel, operative amalgam and foil condenser, endodontic curette, operative curette, periodontic curette, surgical curette, dental surgical elevator, operative dental excavator, operative explorer surgical bone file, operative margin finishing file, periodontic file, periodontic probe, surgical rongeur forceps, surgical tooth extractor forceps, surgical hemostat, periodontic hoe, operative matrix contouring instrument, operative cutting instrument, operative margin finishing periodontic knife, periodontic marker, operative pliers, endodontic root canal plugger, endodontic root canal preparer, surgical biopsy punch, endodontic pulp canal reamer, crown remover, periodontic scaler, collar and crown scissors, endodontic pulp canal filling material spreader, surgical osteotome chisel, endodontic broach, dental wax carver, endodontic pulp canal file, hand instrument for calculus removal, dental depth gauge instrument, plastic dental filling instrument, dental instrument handle, surgical tissue scissors, mouth mirror, orthodontic band driver, orthodontic band pusher, orthodontic band setter, orthodontic bracket aligner, orthodontic pliers, orthodontic ligature tucking instrument, forceps, for articulation paper, forceps for dental dressing, dental matrix band, matrix retainer, dental retractor, dental retractor accessories, periodontic or endodontic irrigating syringe, and restorative or impression material syringe.
Classification Rationale
Class I (general controls). If the device is made of the same materials that were used in the device before May 28, 1976, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
Cleared Devices (31)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K062856 | TF ROTARY NICKEL TITANIUM FILE | Ormco Corp. | Dec 13, 2006 | SESE |
| K004031 | NT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILES | Dental Power, Inc. | Mar 28, 2001 | SESE |
| K971319 | NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILES | Tycom Dental | May 22, 1997 | SESE |
| K970649 | HERO 642 | Micro-Mega | May 16, 1997 | SESE |
| K962031 | QUANTEC SERIES 2000 ENDODONTIC FILES | Tycom Dental | Jun 4, 1996 | SESE |
| K953604 | SHAPING HEDSTROM N.T. | Sybron Dental Specialties, Inc. | Sep 28, 1995 | SESE |
| K935542 | NICKEL-TITANIUM K-TYPE FILE | Union Broach, Div. Moyco Industries, Inc. | Jan 3, 1994 | SESE |
| K932529 | LIGHTSPEED DENTAL HAND INSTRUMENT | Lightspeed Endodontics | Nov 4, 1993 | SESE |
| K933582 | PROFILE SERIES 29 FILES | Tulsa Dental Products, Ltd. | Oct 20, 1993 | SESE |
| K902018 | DENTAURUM CERAMIC DEBONDING UNIT | Dentauraum, Inc. | Apr 3, 1991 | SESE |
| K905640 | SOLID CORE GUTTA PERCHA CARRIER | The Hygenic Corp. | Mar 5, 1991 | SESE |
| K905461 | PROCEDURE KIT/ROUTINE DENTAL PROCEDURES | Angiosystems, Inc. | Mar 5, 1991 | SEKD |
| K901037 | VISIONER 21-A | J. Morita USA, Inc. | Aug 14, 1990 | SESE |
| K897195 | A-COMPANY ELECTROTHERMAL DEBONDING DEVICE (ETD) | A Company, Inc. | May 31, 1990 | SESE |
| K883418 | DE-BOND 200 | Scheu-Dental | Oct 24, 1989 | SESE |
| K892861 | DENTAL PIK | U.S. Dentek Corp. | Sep 15, 1989 | SESE |
| K892894 | S-FILE, S-FINDER, S-ENGINE FILE | Svenska Dental Instruments AB | May 24, 1989 | SESE |
| K873671 | COLTENE PRESIDENT JET IMPRESSION MATERIALS SYSTEM | Coltene, Inc. | Oct 27, 1987 | SESE |
| K864976 | SOLUSET CALCIUM DEMINERALIZING SOLUTION | Endo Technic Corp. | Feb 27, 1987 | SESE |
| K870177 | ENDOBRUSH | C & S Microinstruments , Ltd. | Feb 19, 1987 | SESE |
| K864922 | DENTAL HANDPIECES AND ATTACHMENT | E&D Dental Manufacturing Co. | Feb 19, 1987 | SESE |
| K855136 | FLEXOR FLEXIBLE ROANE TIP ENDODONTIC FILE | Union Broach, Div. Moyco Industries, Inc. | Mar 6, 1986 | SESE |
| K823685 | FILE TYPE H (HEDSTROEM) ENDODONTIC | United Dental Mfg., Inc. | Dec 28, 1982 | SESE |
| K823684 | FILE TYPE K ENDODONTIC | United Dental Mfg., Inc. | Dec 28, 1982 | SESE |
| K823318 | DENTAL INSTRUMENTS - EXCAVATORS | Miltex, Inc. | Nov 24, 1982 | SESE |
| K823316 | DENTAL INSTRUMENTS - FILES | Miltex, Inc. | Nov 24, 1982 | SESE |
| K822622 | ROOT CANAL FILES, TYPE H (HEDSTROM | Union Broach, Div. Moyco Industries, Inc. | Sep 28, 1982 | SESE |
| K822621 | ROOT CANAL FILES, TYPE K | Union Broach, Div. Moyco Industries, Inc. | Sep 28, 1982 | SESE |
| K812692 | FILES & REAMERS | Miltex Instrument Co. | Oct 23, 1981 | SESE |
| K812260 | DYNA TRAK ENDODONTIC PREP. INSTRUMENT | Inventive Technology Int'L., Inc. | Aug 25, 1981 | SESE |
| K800293 | FILE, PULP CANAL | Ipco Corp. | Feb 19, 1980 | SESE |
Top Applicants
- Union Broach, Div. Moyco Industries, Inc. — 4 clearances
- United Dental Mfg., Inc. — 2 clearances
- Tycom Dental — 2 clearances
- Miltex, Inc. — 2 clearances
- U.S. Dentek Corp. — 1 clearance
