EIS · Remover, Crown
Dental · 21 CFR 872.4565 · Class 1
Overview
| Product Code | EIS |
|---|---|
| Device Name | Remover, Crown |
| 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 (19)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K992649 | ATD AUTOMATIC BRIDGE REMOVER | J. Morita USA, Inc. | Oct 29, 1999 | SESE |
| K951299 | EASY PNEUMATIC CROWN AND BRIDGE REMOVER | Dentco, Inc. | Aug 29, 1995 | SESE |
| K863500 | STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CAR | Pacific Union Dental, Inc. | Sep 22, 1986 | SESE |
| K854795 | HAZELTON TEMPORARY CROWN AND BRIDGE REMOVER | Fran Hazelton Co. | Mar 4, 1986 | SESE |
| K842026 | H-TYPE BRIDGE REMOVER | Higa Manufacturing , Ltd. | Jul 11, 1984 | SESE |
| K833290 | C & B 40 PENTRO C & B40 | Genesis Industries, Inc. | Jan 3, 1984 | SESE |
| K833287 | SATIN CAST ECONOCAST | Genesis Industries, Inc. | Jan 3, 1984 | SESE |
| K833736 | GOLD-PALLADIUM-SILVER BASED CAST/ALLOY | Jeneric Ind. | Dec 29, 1983 | SESE |
| K833289 | C & B 61 PENTRON C & B61 | Genesis Industries, Inc. | Dec 29, 1983 | SESE |
| K833278 | C & B 45 | Genesis Industries, Inc. | Dec 29, 1983 | SESE |
| K833280 | SUPRA AP CHOICE 83 | Genesis Industries, Inc. | Dec 26, 1983 | SESE |
| K833285 | RX IV PENTRON IV | Genesis Industries, Inc. | Dec 22, 1983 | SESE |
| K833288 | C & B57 PENTRON C & B57 | Genesis Industries, Inc. | Dec 20, 1983 | SESE |
| K833286 | RX SEG ECONOPLUS | Genesis Industries, Inc. | Nov 28, 1983 | SESE |
| K833284 | RX 41 PENTRON 41 | Genesis Industries, Inc. | Nov 28, 1983 | SESE |
| K833283 | RX ORY PENTRON C & B | Genesis Industries, Inc. | Nov 28, 1983 | SESE |
| K833282 | RX NYSP PENTRON 60 | Genesis Industries, Inc. | Nov 28, 1983 | SESE |
| K833281 | RX D PENTRON | Genesis Industries, Inc. | Nov 28, 1983 | SESE |
| K833279 | NATURELLE-LITE | Genesis Industries, Inc. | Nov 28, 1983 | SESE |
Top Applicants
- Genesis Industries, Inc. — 13 clearances
- Pacific Union Dental, Inc. — 1 clearance
- Jeneric Ind. — 1 clearance
- J. Morita USA, Inc. — 1 clearance
- Higa Manufacturing , Ltd. — 1 clearance
