Product Classification

• Device: liner, cavity, calcium hydroxide
• Regulation Description: Calcium hydroxide cavity liner.
• Regulation Medical Specialty: Dental
• Review Panel: Dental
• Product Code: EJK
• Submission Type: 510(k)
• Regulation Number: 872.3250
• 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 Expansion Pilot Program

Accredited Persons

• dekra certification b.v.
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.