Product Classification

• Device: agent, tooth bonding, resin
• Regulation Description: Resin tooth bonding agent.
• Regulation Medical Specialty: Dental
• Review Panel: Dental
• Product Code: KLE
• Submission Type: 510(k)
• Regulation Number: 872.3200
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standard

• ISO 7405 Second edition 2008-12-15 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry

Third Party Review

• Eligible for Accredited Persons Program

Accredited Persons

• bsi healthcare
• center for measurement standards of industrial
• dekra certification b.v.
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.