DCI WATER PURIFIER

• K Number: K971727
• Device Name: DCI WATER PURIFIER
• Manufacturer: DENTAL COMPONENTS, INC.
• Date Cleared: 1997-09-12 ( 126 days)
• Product Code: EIA
• Regulation Number: 872.6640
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

A device which provides water exposed Ultraviolet for a denta ( conjunction wit operate treatment devices, to veduce Water bacteria in the water number o

Device Description

Not Found

AI/ML Overview

I'm sorry, but this document is a 510(k) clearance letter from the FDA for a dental water purifier. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details, expert qualifications, or ground truth methods from this document.

Regulation Number and Section

§ 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.