Saw, Bone, Ac-powered

Device Code: 1102

Product Code(s): DZH

Device Classification Information

• Device Type ID: 1102
• Device Name: Saw, Bone, Ac-powered
• Regulation Description: Bone Cutting Instrument 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: 872.4120 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: DZH
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

• 4-212 ISO 7405 Second Edition 2008-12-15
  Dentistry - Evaluation Of Biocompatibility Of Medical Devices Used In Dentistry [Including: Amendment 1 (2013)]
• 4-244 ISO 8325 Second Edition 2004-09-15
  Dentistry - Test Methods For Rotary Instruments
• 8-150 ISO 5832-9 Second Edition 2007-06-15
  Implants For Surgery - Metallic Materials - Part 9: Wrought High Nitrogen Stainless Steel
• 8-435 ISO 5832-1 Fifth Edition 2016-07-15
  Implants For Surgery - Metallic Materials - Part 1: Wrought Stainless Steel

Total Product Life Cycle

• Device Type ID: 1102
• Device: Saw, Bone, Ac-powered
• Product Code: DZH
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Bone Cutting Instrument And Accessories.
• CFR Regulation Number: 872.4120 [🔎]

TPLC Last Update: 2019-04-02 19:48:24