Elevator, Surgical, Dental

Device Code: 1259

Product Code(s): EMJ

Device Classification Information

• Device Type ID: 1259
• Device Name: Elevator, Surgical, Dental
• Regulation Description: Dental Hand 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: 872.4565 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: EMJ
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 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: 1259
• Device: Elevator, Surgical, Dental
• Product Code: EMJ
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Dental Hand Instrument.
• CFR Regulation Number: 872.4565 [🔎]

Device Problems
Fracture	235
Break	34
Tip	11
Bent	9
Off-Label Use	3
Material Fragmentation	1
Insufficient Information	1
Component Falling	1
Device Inoperable	1
Material Integrity Problem	1
Use Of Device Problem	1
Total Device Problems	298

TPLC Last Update: 2019-04-02 19:50:49