Plugger, Root Canal, Endodontic

Device Code: 1230

Product Code(s): EKR

Device Classification Information

• Device Type ID: 1230
• Device Name: Plugger, Root Canal, Endodontic
• 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: EKR
• 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: 1230
• Device: Plugger, Root Canal, Endodontic
• Product Code: EKR
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Dental Hand Instrument.
• CFR Regulation Number: 872.4565 [🔎]

Device Problems
Programming Issue	38
Break	8
Application Program Problem: Dose Calculation Error	5
Device Operates Differently Than Expected	2
Insufficient Heating	1
Overheating Of Device	1
Temperature Problem	1
Insufficient Information	1
Plug	1
Material Separation	1
Total Device Problems	59

Recalls
Manufacturer		Recall Class	Date Posted
1	Ormco/Sybronendo	II	Jan-26-2018

TPLC Last Update: 2019-04-02 19:50:20