Product Classification

• Device: unit, operative dental
• Regulation Description: Dental operative unit and accessories.
• Regulation Medical Specialty: Dental
• Review Panel: Dental
• Product Code: EIA
• Premarket Review: Division of Dental and ENT Devices (DHT1B); Division of Dental and ENT Devices (DHT1B)
• Submission Type: 510(k)
• Regulation Number: 872.6640
• 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

• 4-180 ISO 9168 Third edition 2009-07-15
  Dentistry - Hose connectors for air driven dental handpieces
• 4-221 ISO 7494-2 Second edition 2015-04-01
  Dentistry - Dental units - Part 2: Air, water, suction and waste water systems
• 4-244 ISO 8325 Second edition 2004-09-15
  Dentistry - Test methods for rotary instruments
• 4-250 ISO 7494-1 Third edition 2018-06
  Dentistry - Stationary dental units and dental patient chairs - Part 1: General requirements
• 4-261 ISO 7405 Third edition 2018-10 Corrected version 2018-12
  Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
• 4-262 IEC 80601-2-60 Edition 2.0 2019-06
  Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
• 4-269 ISO 3964 Third edition 11-2016
  Dentistry - Coupling dimensions for handpiece connectors [Including AMENDMENT 1 (2018)]
• 4-276 ISO 14457 Second edition 2017-10
  Dentistry - Handpieces and motors
• 4-281 ISO 1797 Third Edition 2017-05
  Dentistry - Shanks for rotary and oscillating instruments
• 4-305 ISO 10637 Second edition 2018-05
  Dentistry - Central suction source equipment
• 4-306 ISO 22052 First edition 2020-06
  Dentistry - Compressed air source equipment
• 4-314 ISO 7494-2 Third edition 2022-07
  Dentistry - Stationary dental units and dental patient chairs - Part 2: Air, water, suction and wastewater systems
• 4-317 ISO 8325 Third edition 2023-03
  Dentistry - Test methods for rotary instruments

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