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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bracket, plastic, orthodontic
Product CodeDYW
Regulation Number 872.5470
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMERS PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
BLUE SKY BIO
  SUBSTANTIALLY EQUIVALENT 1
BRACES ON DEMAND, INC
  SUBSTANTIALLY EQUIVALENT 1
CADENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY INTERNTIONAL
  SUBSTANTIALLY EQUIVALENT 1
GREAT LAKES ORTHODONTICS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
ORACREW
  SUBSTANTIALLY EQUIVALENT 1
ORMCO CORP.
  SUBSTANTIALLY EQUIVALENT 4
ORTHO ORGANIZERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHO SPECIALTIES
  SUBSTANTIALLY EQUIVALENT 1
TOMY, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 4 4
2015 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Migration or Expulsion of Device 3 3
Insufficient Information 2 2
Loose or Intermittent Connection 1 1
Nonstandard Device 1 1
Failure to Osseointegrate 1 1
Fitting Problem 1 1
Device Markings/Labelling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 2 2
No Code Available 2 2
Hypersensitivity/Allergic reaction 1 1
Tissue Damage 1 1
Tooth Fracture 1 1
Foreign Body In Patient 1 1
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ormco Corporation III Nov-16-2011
2 Ormco/Sybronendo II Apr-04-2014
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