EIC · Syringe, Periodontic, Endodontic, Irrigating
Dental · 21 CFR 872.4565 · Class 1
Overview
| Product Code | EIC |
|---|---|
| Device Name | Syringe, Periodontic, Endodontic, Irrigating |
| 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 (16)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K972234 | RCT GEL ROOT CANAL THERAPY GEL | Dentsply Intl. | Jun 30, 1997 | SESE |
| K864307 | MAX-I-PROBE PERIDONTAL/ENDODONTIC PROBE(TM) (MODI) | Smith & Nephew, Inc. | Nov 18, 1986 | SESE |
| K861846 | HYDRON ROOT CANAL FILLING & MARK IV STARTER KIT | Solar Dental Co., Inc. | Jun 26, 1986 | SESE |
| K851944 | MAX-I-PROBE HANDPIECE | Solo Pak Laboratories | Jul 1, 1985 | SESE |
| K840237 | MAX-I-PROBE PERIODONTAL ENDODONTIC PROB | Smith & Nephew, Mpl Division | Apr 5, 1984 | SESE |
| K811889 | R & S SERIES FITTING TOOLS | Suncoast Dental Corp. | Jul 24, 1981 | SESE |
| K811594 | WATER PISTOL | Aus-Tex Dental Mfg. & Design | Jul 15, 1981 | SESE |
| K801484 | ROOT CANAL FILLING APPLICATOR NEEDLES | National Patent Development Corp. | Jul 21, 1980 | SESE |
| K801483 | MARK IV SYRINGE | National Patent Development Corp. | Jul 21, 1980 | SESE |
| K792578 | EPIC CANNULA | Dental Development Services, Inc. | Jan 4, 1980 | SESE |
| K792577 | ENDOVAGE SYRINGE | Dental Development Services, Inc. | Jan 4, 1980 | SESE |
| K792461 | CENTRIX MKIV ENDODONTIC DELIVERY | Centrix, Inc. | Dec 19, 1979 | SESE |
| K771406 | GUTTA GUN | Aus-Tex Dental Mfg. & Design | Aug 26, 1977 | SESE |
| K770967 | SYRINGE, ENDODONTIC, W/PERFORATED NEEDLE | National Patent Development Corp. | Jun 20, 1977 | SESE |
| K770813 | ENDOGATOR | Aus-Tex Dental Mfg. & Design | May 20, 1977 | SESE |
| K770642 | SYRINGE, ENDODONTIC W/NOTCHED TIP NEEDLE | National Patent Development Corp. | Apr 15, 1977 | SESE |
Top Applicants
- National Patent Development Corp. — 4 clearances
- Aus-Tex Dental Mfg. & Design — 3 clearances
- Dental Development Services, Inc. — 2 clearances
- Suncoast Dental Corp. — 1 clearance
- Solo Pak Laboratories — 1 clearance
