Bracket, Metal, Orthodontic

Device Code: 1197

Product Code(s): EJF

Device Classification Information

• Device Type ID: 1197
• Device Name: Bracket, Metal, Orthodontic
• Regulation Description: Orthodontic Appliance 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) Exempt
• CFR Regulation Number: 872.5410 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: EJF
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 4-218 ISO 27020 First Edition 2010-12-15
  Dentistry - Brackets And Tubes For Use In Orthodontics
• 8-150 ISO 5832-9 Second Edition 2007-06-15
  Implants For Surgery - Metallic Materials - Part 9: Wrought High Nitrogen Stainless Steel

Total Product Life Cycle

• Device Type ID: 1197
• Device: Bracket, Metal, Orthodontic
• Product Code: EJF
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Orthodontic Appliance And Accessories.
• CFR Regulation Number: 872.5410 [🔎]

Device Problems
Improper Or Incorrect Procedure Or Method	5
Adverse Event Without Identified Device Or Use Problem	4
Patient-Device Incompatibility	2
Difficult To Remove	1
Solder Joint Fracture	1
Total Device Problems	13

Recalls
Manufacturer		Recall Class	Date Posted
1	Ormco/Sybronendo	II	Apr-02-2014

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