DENTACENTER/EXPEDITION, MODEL SAF-430

• K Number: K100212
• Device Name: DENTACENTER/EXPEDITION, MODEL SAF-430
• Manufacturer: SAFARI DENTAL, INC.
• Date Cleared: 2010-10-22 ( 270 days)
• Product Code: EIA
• Regulation Number: 872.6640
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Dentacenter offers the dental professional the capability of carrying a complete dental operative system in one transportable case. The system is ideally suited for performing general dental procedures anywhere there is a suitable power source.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding a "DENTACENTER / EXPEDITION MODEL Mobile Dental Operative Unit." It describes the regulatory classification and general information about marketing the device.

This document does not contain any information about acceptance criteria for device performance, clinical study details, or the evaluation of an AI-powered device. Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance as the necessary information is not present in the provided text.

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.