Product Classification

• Device: chair, dental, with operative unit
• Regulation Description: Dental chair and accessories.
• Regulation Medical Specialty: Dental
• Review Panel: Dental
• Product Code: KLC
• 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: 872.6250
• Device Class: 1
• 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

• 4-305 ISO 10637 Second edition 2018-05
  Dentistry - Central suction source equipment
• 4-334 ISO 11143 Second edition 2008-07
  Dentistry - Amalgam separators
• 4-340 ADA ANSI Standard No. 46-2016
  Dental Patient Chair
• 4-341 ADA ANSI Standard No. 47-1-2021
  Stationary Dental Units and Patient Chairs-Part 1: General Requirements
• 4-342 ADA ANSI Standard No. 47-2-2021
  Stationary Dental Units and Patient Chairs-Part 2: Air, Water, Suction and Wastewater Systems

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc