VIOLA II DENTAL CAMERA SYSTEM

• K Number: K973035
• Device Name: VIOLA II DENTAL CAMERA SYSTEM
• Manufacturer: INNOVATIVE MEDICAL SYSTEMS, INC.
• Date Cleared: 1997-09-24 ( 41 days)
• Product Code: EIA
• Regulation Number: 872.6640
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The Viola II Dental Camera system is designed for use in the following applications:

1. To allow the clinician to provide the patient with accurate information
2. To allow the clinician to provide educational information to the patient as well as other clinical personnel
3. To provide documentation for patient records
4. To assist the clinician in the diagnosis of oral cancer and gum diseases
5. To provide documentation for insurance companies

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification for the "Viola II Dental Camera System" and mainly discusses regulatory approval based on substantial equivalence to a predicate device. It does not contain detailed information about acceptance criteria or a specific study proving the device meets acceptance criteria.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document is a regulatory approval letter and an indications for use statement, not a performance study report.

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.