CL-DC20, CL-DC21

• K Number: K093751
• Device Name: CL-DC20, CL-DC21
• Manufacturer: GOOD DOCTORS CO., LTD.
• Date Cleared: 2010-02-24 ( 79 days)
• Product Code: EBZ
• Regulation Number: 872.6070
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

The CL-DC20 and CL-DC21 Dental Curing Lights are indicated for the curing of dental composites using visible light.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any study details that would allow me to answer your request. The document is an FDA 510(k) clearance letter for dental curing lights, which confirms the device's substantial equivalence to a predicate device but does not include the detailed study information you've requested.

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.