Bracket, Metal, Orthodontic

Device Code: 1197

Product Code(s): EJF

Device Classification Information

Device Type ID1197
Device NameBracket, Metal, Orthodontic
Regulation DescriptionOrthodontic Appliance And Accessories.
Regulation Medical SpecialtyDental
Review PanelDental
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
Dental Devices Branch (DEDB)
Submission Type510(K) Exempt
CFR Regulation Number872.5410 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeEJF
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1197
DeviceBracket, Metal, Orthodontic
Product CodeEJF
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionOrthodontic Appliance And Accessories.
CFR Regulation Number872.5410 [🔎]
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

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