(79 days)
The TF Rotary Nickel Titanium File is a rotary endodontic file designed for use in root canal preparation.
The TF Rotary Nickel Titanium File is an engine (rotary) driven endodontic file intended for use in root canal preparation. The TF Rotary Nickel Titanium File is made from a single bar stock of nickel titanium that is machined and formed to create a single-piece file (handle, shaft and working portion).
Flutes are ground throughout the working portion, forming the cutting edges of the instrument and creating a tapered triangular cross-section. The file blank is heat annealed and the working portion is twisted to form helical cutting edges. The file is twisted instead of ground which enhances its flexibility and durability.
The TF Rotary Nickel Titanium File has a non-cuttting (passive) tip and variable helical flute angle. The single-piece unit is intended to prevent separation of the handle from the shaft/working portion.
This document is a 510(k) Summary of Safety and Effectiveness for a medical device (TF Rotary Nickel Titanium File), submitted to the FDA. It does not contain information about acceptance criteria or a study proving that the device meets those criteria in the context of an AI/algorithm-driven device.
The TF Rotary Nickel Titanium File is a physical dental instrument, not an AI or algorithm-driven device. Therefore, the questions related to AI/algorithm performance, such as sample sizes for test/training sets, ground truth establishment by experts, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable to this document.
The document primarily focuses on establishing substantial equivalence to a predicate conventional dental instrument. The "acceptance criteria" for a device like this would typically involve mechanical and material property testing (e.g., flexibility, durability, resistance to fracture, biocompatibility), manufacturing quality controls, and performance in simulated root canals or in vivo studies to demonstrate its ability to prepare a root canal safely and effectively. However, this specific 510(k) summary does not detail the individual tests or "acceptance criteria" and their results. It broadly states that the device "functions in a manner similar to and is intended for the same use" as a legally marketed predicate device, implying that it meets similar performance standards.
§ 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.