CUTE-LITE I LIGHT CURE UNIT

• K Number: K991863
• Device Name: CUTE-LITE I LIGHT CURE UNIT
• Manufacturer: ROLENCE ENTERPRISE CO. LTD.
• Date Cleared: 1999-07-19 ( 48 days)
• Product Code: EBZ
• Regulation Number: 872.6070
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

TO PRODUCE LIGHT RANGE BETWEEN 400 & 500 NM TO POLYMERIZE LIGHT CURED DENTAL RESTORATIVE MATERIAL SUCH AS LIGHT CURE COMPOSITES, PIT AND FISSURE SEALANTS, BONDING AGENTS, ADHESION PRIMERS ETC. WHICH ARE APPLIED IN THE RESTORATION OF FUCTION AND APPEARANCE OF THE TEETH OF PATIENT.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification approval letter for a dental light cure unit (Cute-Lite I Light Cure Unit). This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment related to an AI or algorithm-driven device.

The letter is a regulatory approval for a physical medical device (a light cure unit) based on its substantial equivalence to previously marketed devices, following the provisions of the Federal Food, Drug, and Cosmetic Act. It primarily discusses regulatory classifications, general controls, and compliance requirements.

Therefore, I cannot provide details for the requested questions as the input document does not contain this type of information.

Regulation Number and Section

§ 872.6070 Ultraviolet activator for polymerization.

(a)
Identification. An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.(b)
Classification. Class II.