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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device adhesive, bracket and tooth conditioner, resin
Regulation Description Bracket adhesive resin and tooth conditioner.
Product CodeDYH
Regulation Number 872.3750
Device Class 2


Premarket Reviews
ManufacturerDecision
AMERICAN ORTHODONTICS
  SUBSTANTIALLY EQUIVALENT 2
DANVILLE MATERIALS, LLC.
  SUBSTANTIALLY EQUIVALENT 2
DENTSCARE LTDA
  SUBSTANTIALLY EQUIVALENT 1
GC ORTHODONTICS
  SUBSTANTIALLY EQUIVALENT 2
PULPDENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
VOCO GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 2 2
2016 1 1
2017 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5 5
Patient-Device Incompatibility 2 2
Device Operates Differently Than Expected 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Tooth Fracture 3 3
Reaction 2 2
Sensitivity of Teeth 1 1
Eye Injury 1 1
Headache 1 1
Pain 1 1
Swelling 1 1
Dizziness 1 1

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