EKJ · Burnisher, Operative
Dental · 21 CFR 872.4565 · Class 1
Overview
| Product Code | EKJ |
|---|---|
| Device Name | Burnisher, Operative |
| 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.
Recent Cleared Devices (20 of 72)
Showing 20 most recent of 72 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K961714 | ASEPTYLUM, UNI-CARRIER | Distriflor S.A. | Jun 10, 1996 | SESE |
| K953707 | MEDTROL DENTAL KIT | Medtrol, Inc. | Jan 4, 1996 | SESE |
| K945815 | DENTAL KIT | Constancy Ent., Inc. | Jul 19, 1995 | SESE |
| K951607 | SUREFLEX FILES | Dentsply Intl. | Jun 22, 1995 | SESE |
| K945077 | INSTRUMENT,FILLING,PLASTIC,DENTAL | Worldwide Dental, Inc. | Nov 30, 1994 | SESE |
| K943820 | STAT PAK | Magnum Instruments, Inc. | Nov 2, 1994 | SESE |
| K943351 | MAUNAL DISPOSABLE DENTAL INSTRUMENTS | Magnum Instruments, Inc. | Oct 7, 1994 | SESE |
| K943584 | PRESTERILIZED ENDODONTIC FILES | Dentsply Intl. | Sep 21, 1994 | SESE |
| K935127 | SOUTHLAND STERILE DENTAL SYSTEM | Southland, Ltd. | Jul 28, 1994 | SESE |
| K941954 | NON-FOGGING DENTAL MIRROR | Buffalo Dental Mfg. Co., Inc. | Jul 8, 1994 | SESE |
| K925115 | AMD DENTIST AND HYGIENIST KITS | Advance Medical Designs, Inc. | Jul 5, 1994 | SESE |
| K925890 | MIRROR, MOUTH | Protector, Inc. | Feb 15, 1994 | SESE |
| K925889 | FORCEPS, DRESSING, DENTAL | Protector, Inc. | Feb 15, 1994 | SESE |
| K925888 | EXPLORER, OPERATIVE | Protector, Inc. | Feb 15, 1994 | SESE |
| K935217 | LC DENTAL HAND INSTRUMENT | L.C. Dental | Jan 5, 1994 | SESE |
| K932511 | SILICONE MIRROR | Moyco Industries, Inc. | Nov 5, 1993 | SESE |
| K926368 | APPLICATOR NOZZLE | Centrix, Inc. | Sep 15, 1993 | SESE |
| K923902 | STERILE DENTAL KITS | Professional Sterile Systems, Inc. | Jun 29, 1993 | SESE |
| K922988 | ECO/DENTAL GENERAL DENTAL PACK | Dyna-Pace Systems, Inc. | Nov 4, 1992 | SESE |
| K921354 | BLUNT TIP IRRIGATION NEEDLES | Innovators, Inc. | Sep 25, 1992 | SESE |
Top Applicants
- American Medical Ceramics, Inc. — 11 clearances
- Centrix, Inc. — 4 clearances
- Brevet, Inc. — 3 clearances
- Dentsply Intl. — 3 clearances
- Protector, Inc. — 3 clearances
