(243 days)
Absolute America is a dental operative unit intended as an operative tool for therapeutic use on people by personnel highly skilled in dental practices, such as dentists, dental assistants and dental hygienists.
Eurodent dental operative unit is an electrical device with air and water connections. It is composed from:
- A patient treatment chair moved electrically -
- an hydric group with cuspidor and inside all suction , water, air and electrical circuits ・
- a dentist's instrument board -
- an assistant board -
- an electrical footswitch that controls same unit functions -
- a dental light
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.
The document is a 510(k) summary for a dental operative unit, and it primarily focuses on:
- Device Description: What the device is composed of.
- Intended Use: How the device is meant to be used and by whom.
- Summary of Substantial Equivalence Comparison: Comparing the device to legally marketed predicate devices, stating they use similar components, design, technical characteristics, and mode of operation.
- FDA Communication: A letter from the FDA confirming the substantial equivalence determination, allowing the device to be marketed, and outlining regulatory requirements.
- Indication for Use form: Reiteration of the intended use.
This type of submission (510(k)) for a Class I device often relies on demonstrating substantial equivalence to a predicate device rather than extensive clinical studies with specific performance metrics and acceptance criteria as one might find for a Class II or Class III device. Therefore, the detailed study information you are asking for is not present in this document.
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.