(79 days)
Pro-Dentec's VICTOR Interactive Probe is an automated periodontal probe intended for use during periodontal examinations to measure and chart the depth of a gingival sulcus in millimeters.
The device is a periodontal probe which is used by dental professionals during periodontal examinations. The device consists of a control unit, a transducer connected by a cable to the control unit and single use, disposable handpieces.
The provided document is a 510(k) summary for the Pro-Dentec VICTOR Interactive Probe, an Electronic Periodontal Probe. It describes the device, its intended use, and identifies a predicate device (Florida Probe K875076 and manual Michigan periodontal probes).
However, the document does not contain any information about acceptance criteria, performance studies, sample sizes, ground truth establishment, expert involvement, or any of the other specific details requested in your prompt.
This 510(k) summary focuses on establishing substantial equivalence to a predicate device, which often relies on demonstrating similar technological characteristics and intended use, rather than presenting detailed clinical performance data in the same way a de novo submission or a more comprehensive clinical trial report would.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The requested information is simply not present in this document.
§ 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.