(335 days)
The Elements Obturation Unit is intended to be used in Dentistry to:
- Provide continuous heat at the tip of a dental instrument to test tooth response to thermal stimulus,
- For tissue cauterization and coagulation, and
- To backfill and downpack gutta percha during Endodontic root canal treatment.
- When in Extruder mode, the Elements Obturation Unit is used only to backfill gutta percha during root canal obturation.
The device is an AC powered endodontic unit designed to be used in either of two modes, a) the System B Mode to 1) downpack and backfill gutta percha during root canal obturation, 2) test tooth response to thermal stimulus (Hot Pulp Test) and 3) for tissue cautery, and b) the Extruder Mode to backfill gutta percha during root canal obturation. The unit has an LCD screen with membrane switch controls. When using the unit in the System B Mode, the user may select the appropriate switch to downpack, backfill, cauterize or hot pulp test. While the temperature has a preset value with each of the four selections, it can also be adjusted using the temperature adjust button. In the Extruder Mode, the user may select the gutta percha type (alpha or beta), speed of extrusion (high or low), alarm sound setting and volume/mode, The endodontic obturation unit is controlled by a microprocessor that is designed to support a network style communication allowing information to be shared between endodontic devices. The System B and Extrusion hand pieces are completely removable and autoclavable.
The provided text is a 510(k) Summary for the "Elements Obturation Unit," a dental device. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment.
The document is a regulatory submission for premarket notification, focusing on demonstrating that the device is "substantially equivalent" to already legally marketed devices. This regulatory pathway typically relies on comparing the new device's technological characteristics and intended use to a predicate device, rather than requiring formal clinical trials or new performance studies to demonstrate safety and effectiveness from scratch.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as the provided text does not contain this information.
§ 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.