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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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
3M UNITEK ORTHODONTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
AMERICAN ORTHODONTICS
  SUBSTANTIALLY EQUIVALENT 2
AMERICAN ORTHODONTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
DENTSCARE LTDA
  SUBSTANTIALLY EQUIVALENT 1
LARGENT HEALTH, LLC
  SUBSTANTIALLY EQUIVALENT 1
ORMCO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
RELIANCE ORTHODONTIC PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPIDENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TP ORTHODONTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VOCO GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2025 1 1
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Device Interaction Problem 1 1
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Urticaria 1 1
Superficial (First Degree) Burn 1 1

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