Product Classification

• Device: dental amalgam
• Regulation Description: Dental amalgam, mercury, and amalgam alloy.
• Definition: Dental amalgam is a device that consists of a metallic alloy, such as silver, tin, copper, and zinc, that is mixed with liquid elemental mercury for the direct filling of carious lesions or structural defects in teeth
• Physical State: Powder and liquid metals encapsulated and separated by a septum. Forms a solid upon mixing.
• Technical Method: Heterogeneous mixture of alloy and elemental mercury hardens to form a solid that is used as a direct filling material
• Target Area: Direct filling of teeth.
• Regulation Medical Specialty: Dental
• Review Panel: Dental
• Product Code: OIV
• Premarket Review: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1); Division of Dental and ENT Devices (DHT1B)
• Submission Type: 510(k)
• Regulation Number: 872.3070
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 4-246 ISO 20749 First edition 2017-03
  Dentistry - Pre-capsulated dental amalgam
• 4-295 ADA ANSI Standard No. 41-2020
  Evaluation of Biocompatibility of Medical Devices Used in Dentistry
• 4-318 ISO 20749 Second edition 2023-06
  Dentistry - Pre-capsulated dental amalgam

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 510(k) Third Party Review Program

Accredited Persons

• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc