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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mouthguard, over-the-counter
Definition To protect the teeth and reduce damage caused by bruxing or nighttime grinding and prevention of the noise associated with bruxing and grinding.
Product CodeOBR
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
BOYD RESEARCH, INC.
  SUBSTANTIALLY EQUIVALENT 2
DENTAL CHOICE HOLDINGS, LLC
  SUBSTANTIALLY EQUIVALENT 1
DIMEDIKOREA
  SUBSTANTIALLY EQUIVALENT 1
DOC BRANDS, INC.
  SUBSTANTIALLY EQUIVALENT 1
FBCC INC
  SUBSTANTIALLY EQUIVALENT 1
KONCEPT INNOVATORS, LLC.
  SUBSTANTIALLY EQUIVALENT 1
MCKEON PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
MEDTECH PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
REAZEAL CORP
  SUBSTANTIALLY EQUIVALENT 1
SPLINTEK, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 29 29
2020 15 15
2021 10 10
2022 6 6
2023 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 9 9
Patient-Device Incompatibility 8 8
Break 7 7
Product Quality Problem 5 5
Improper or Incorrect Procedure or Method 5 5
Fitting Problem 5 5
Component Missing 3 3
Material Separation 3 3
Unexpected Therapeutic Results 2 2
Crack 2 2
Material Disintegration 2 2
Entrapment of Device 2 2
Material Fragmentation 2 2
Detachment of Device or Device Component 2 2
Material Integrity Problem 2 2
Insufficient Information 2 2
Material Split, Cut or Torn 2 2
Device Fell 1 1
Separation Problem 1 1
Scratched Material 1 1
Therapeutic or Diagnostic Output Failure 1 1
No Apparent Adverse Event 1 1
Naturally Worn 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Malposition of Device 1 1
Device Emits Odor 1 1
Peeled/Delaminated 1 1
Use of Device Problem 1 1
Inadequacy of Device Shape and/or Size 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 20 20
Foreign Body In Patient 7 7
Pain 6 6
Insufficient Information 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
No Code Available 5 5
Swelling 5 5
Choking 5 5
Reaction 3 3
No Clinical Signs, Symptoms or Conditions 3 3
Discomfort 2 2
Deformity/ Disfigurement 2 2
Patient Problem/Medical Problem 2 2
Hypersensitivity/Allergic reaction 2 2
Irritation 1 1
Abdominal Pain 1 1
Chest Pain 1 1
Hemorrhage/Bleeding 1 1
Therapeutic Response, Decreased 1 1
Anxiety 1 1
Rash 1 1
Skin Discoloration 1 1
Abdominal Distention 1 1
Sensitivity of Teeth 1 1
Sweating 1 1
Joint Contracture 1 1

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