CU-100A LIGHT CURE UNIT

• K Number: K980792
• Device Name: CU-100A LIGHT CURE UNIT
• Manufacturer: ROLENCE ENTERPRISE CO. LTD.
• Date Cleared: 1998-05-15 ( 74 days)
• Product Code: EBF
• Regulation Number: 872.3690
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

TO PRODUCE LIGHT FOR FORME MATERIAL SUCH AS LIGHT CURE COMPOSITES, CURE DENTAL RESTORATIVE MATERIAL SUCH AS LIGHT CURE COMPOSITES , CURE DENTAL RESTORATIVE MATERIAL SUCH AS LIGHT CURE COMESSITES , CURE DENTAL SESTORATIVE BONDING AGENTS, ADENTS, ADHESTON PRIMERS ETC. PIT AND FISSURE SEALANTS, BONDING AGENTS, FECTION AND APPEARANCE 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 letter from the FDA regarding a 510(k) premarket notification for a dental light cure unit. It does not contain information about acceptance criteria or a study that proves the device meets specific criteria. The letter primarily informs the manufacturer that their device, the CU-100A Light Cure Unit, has been determined substantially equivalent to legally marketed predicate devices.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth from the provided text.

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.