Handpiece, Water-powered

Device Code: 1235

Product Code(s): EKY

Device Classification Information

• Device Type ID: 1235
• Device Name: Handpiece, Water-powered
• Regulation Description: Dental Handpiece And Accessories.
• 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)
• CFR Regulation Number: 872.4200 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: EKY
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Program

Recognized Standards

• 4-180 ISO 9168 Third Edition 2009-07-15
  Dentistry - Hose Connectors For Air Driven Dental Handpieces
• 4-206 ISO 14457 First Edition 2012-09-15
  Dentistry - Handpieces And Motors
• 4-229 IEC 80601-2-60 Edition 1.0 2012-02
  Medical Electrical Equipment - Part 2-60: Particular Requirements For The Basic Safety And Essential Performance Of Dental Equipment
• 4-244 ISO 8325 Second Edition 2004-09-15
  Dentistry - Test Methods For Rotary Instruments

Total Product Life Cycle

• Device Type ID: 1235
• Device: Handpiece, Water-powered
• Product Code: EKY
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Dental Handpiece And Accessories.
• CFR Regulation Number: 872.4200 [🔎]

TPLC Last Update: 2019-04-02 19:50:25