COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM

• K Number: K022224
• Device Name: COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM
• Manufacturer: COLTENE AG
• Date Cleared: 2002-09-18 ( 70 days)
• Product Code: DYH
• Regulation Number: 872.3750
• Type: Traditional
• Panel: Dental
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

For the cementation/affixing of metal and/or ceramic orthodontic brackets to teeth.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA regarding the "Cool Bond Light Cured Bracket Adhesive System." It does not contain information about acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is not present in the provided text.

Regulation Number and Section

§ 872.3750 Bracket adhesive resin and tooth conditioner.

(a)
Identification. A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.(b)
Classification. Class II.