Product Classification

• Device: alloy, amalgam
• Regulation Description: Dental amalgam, mercury, and amalgam alloy.
• Regulation Medical Specialty: Dental
• Review Panel: Dental
• Product Code: EJJ
• Submission Type: 510(k)
• Regulation Number: 872.3070
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• ISO 7405 Second edition 2008-12-15 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
• ISO 24234 First edition 2004-10-15 Dentistry - Mercury and alloys for dental amalgam - First edition
• ISO 24234 First edition 2004-10-15 Dentistry -- Mercury and alloys for dental amalgam AMENDMENT 1

Guidance Document

• Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy - Guidance for Industry and FDA Staff

Third Party Review

• Eligible for Accredited Persons Expansion Pilot Program