(11 days)
The Quantec Series 2000 Endodontic Files are designed for use in root canal preparation.
The Quantec Series 2000 Endodontic Files are a series hand driven and engine (rotary) driven endodontic files for use in root canal preparation. The files are constructed of nickel-titanium and color coded for ease of use. The files are available in 17, 21 and 25mm lengths and ten graduating sizes.
This document is a 510(k) summary for the Quantec Series 2000 Endodontic File and does not contain information about acceptance criteria or a study proving device performance against such criteria.
The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices (Tulsa Dental Profile 29 Series and Dentsply SureFlex Endodontic Files) based on intended use and technological characteristics. It does not include performance metrics or clinical study results typical for establishing acceptance criteria for AI/algorithm-based devices.
Therefore, I cannot provide the requested information in the format of a table or answer the specific questions about sample sizes, ground truth, experts, or MRMC studies, as these details are not present in the provided text.
§ 872.4565 Dental hand instrument.
(a)
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.(b)
Classification. 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.