Product Classification

• Device: instrument, diamond, dental, reprocessed
• Regulation Description: Dental diamond instrument.
• Definition: same as DZP except reprocessed
• Regulation Medical Specialty: Dental
• Review Panel: Dental
• Product Code: NLD
• Premarket Review: Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1); Dental Devices (DHT1B)
• Submission Type: 510(k)
• Regulation Number: 872.4535
• Device Class: 1
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible

Recognized Consensus Standard

• 4-244 ISO 8325 Second edition 2004-09-15
  Dentistry - Test methods for rotary instruments

• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

• Eligible for Accredited Persons Program

Accredited Persons

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