Product Classification

• Device: prophy powder, airbrush accessory
• Regulation Description: Airbrush.
• Definition: An air polishing powder to be used with an airbrush for prophylaxis in the oral cavity.
• Physical State: Powder
• Technical Method: The powder is dispensed via an electric airbrush and removes plaque via abrasion of the tooth surface by the powder granules.
• Target Area: Oral cavity
• Regulation Medical Specialty: Dental
• Review Panel: Dental
• Product Code: PIP
• Premarket Review: Division of Dental and ENT Devices (DHT1B); Division of Dental and ENT Devices (DHT1B)
• Submission Type: 510(k)
• Regulation Number: 872.6080
• 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 Standard

• 4-337 ISO 20608 First edition 2018-04
  Dentistry - Powder jet handpieces and powders

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