Product Classification

• Device: driver, wire, and bone drill, manual
• Regulation Description: Bone cutting instrument and accessories.
• Regulation Medical Specialty: Dental
• Review Panel: Dental
• Product Code: DZJ
• 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: 872.4120
• 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

• 4-244 ISO 8325 Second edition 2004-09-15
  Dentistry - Test methods for rotary instruments
• 4-261 ISO 7405 Third edition 2018-10 Corrected version 2018-12
  Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
• 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
• 4-317 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

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