Instrument, Diamond, Dental

Device Code: 1109

Product Code(s): DZP

Device Classification Information

• Device Type ID: 1109
• Device Name: Instrument, Diamond, Dental
• Regulation Description: Dental Diamond Instrument.
• Regulation Medical Specialty: Dental
• Review Panel: Dental
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID); Dental Devices Branch (DEDB)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 872.4535 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: DZP
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 4-244 ISO 8325 Second Edition 2004-09-15
  Dentistry - Test Methods For Rotary Instruments

Total Product Life Cycle

• Device Type ID: 1109
• Device: Instrument, Diamond, Dental
• Product Code: DZP
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Dental Diamond Instrument.
• CFR Regulation Number: 872.4535 [🔎]

Device Problems
Entrapment Of Device	1
Break	1
Total Device Problems	2

TPLC Last Update: 2019-04-02 19:48:30