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K Number
K984584
Device Name
AIR TECHNIQUES' DENTO-VAC
Manufacturer
AIR TECHNIQUES, INC.
Date Cleared
1999-03-22

(88 days)

Product Code
EIA
Regulation Number
872.6640
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The DENTO-VAC device is used for extra-oral evacuation of solid airborne particles from the oral cavity during dental Air Abrasion procedures.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any studies conducted on the Air Techniques Dento-Vac. The document is a 510(k) clearance letter from the FDA, which states that the device is substantially equivalent to legally marketed predicate devices. It does not contain details about performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot provide the requested table and information.

§ 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.