(72 days)
The Plaque Scraper-A Interproximal (between teeth) Plaque Remover is an effective cleansing device which removes plaque and food between the teeth as part of a program for good oral hygiene to supplement the regular professional care required for oral health. This product is intended for personal oral hygiene use.
The Plaque Remover is a plastic product designed with an elongated handle for ergonomic convenience and has dual rounded and beveled points on each end.
The provided text is a 510(k) summary for the "Plaque Scraper-A Interproximal (between teeth) Plaque Remover." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific performance acceptance criteria and results from a clinical trial.
Therefore, the requested information elements such as acceptance criteria, reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance studies, and types of ground truth cannot be extracted from this document, as they are not present.
The summary states:
"The information in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to devices already in commercial distribution. Equivalence is demonstrated through intended use, materials and design."
This indicates that the submission relies on a comparison of intended use, materials, and design features to establish substantial equivalence with a legally marketed predicate device (Reach Stim-U-Dent Plaque Remover), rather than providing performance data from a specific study against predefined acceptance criteria.
§ 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.