Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device bracket, metal, orthodontic
Regulation Description Orthodontic appliance and accessories.
Product CodeEJF
Regulation Number 872.5410
Device Class 1

MDR Year MDR Reports MDR Events
2021 1 1
2022 7 7
2023 6 6
2024 2 2
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Device Interaction Problem 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Insufficient Information 3 3
Biocompatibility 3 3
Use of Device Problem 2 2
Sharp Edges 2 2
Patient-Device Incompatibility 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypersensitivity/Allergic reaction 5 5
Tooth Fracture 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Abrasion 3 3
Shaking/Tremors 3 3
Abdominal Pain 2 2
Sleep Dysfunction 2 2
Nausea 2 2
Dizziness 2 2
Foreign Body Reaction 2 2
Depression 2 2
Blurred Vision 2 2
Headache 2 2
Hot Flashes/Flushes 2 2
Irritability 2 2
Syncope/Fainting 1 1
Arthralgia 1 1
Fatigue 1 1
Metal Related Pathology 1 1
Skin Inflammation/ Irritation 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Neck Pain 1 1
Diarrhea 1 1
Erythema 1 1
Vomiting 1 1
Visual Impairment 1 1
Swelling/ Edema 1 1
Inadequate Pain Relief 1 1

-
-