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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
1987 MEDIA LIMITED
  SUBSTANTIALLY EQUIVALENT 1
ASESSO HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOYD RESEARCH, INC.
  SUBSTANTIALLY EQUIVALENT 1
DIMEDIKOREA
  SUBSTANTIALLY EQUIVALENT 1
DOC BRANDS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ENCORE GUARDS
  SUBSTANTIALLY EQUIVALENT 1
FBCC, INC.
  SUBSTANTIALLY EQUIVALENT 1
OWL DENTAL LAB, INC.
  SUBSTANTIALLY EQUIVALENT 1
REAZEAL CORP
  SUBSTANTIALLY EQUIVALENT 1
REMI
  SUBSTANTIALLY EQUIVALENT 1
SPLINTEK, INC.
  SUBSTANTIALLY EQUIVALENT 1
XIAMEN YIZHOU IMP. & EXP. CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 10 10
2022 6 6
2023 5 5
2024 18 18
2025 13 13
2026 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 23 23
Insufficient Device Problem Information 6 6
Device Emits Odor 3 3
Fitting Problem 2 2
Off-Label Use 2 2
Patient Device Interaction Problem 2 2
Use of Device Problem 2 2
Chemical Problem 1 1
Patient-Device Incompatibility 1 1
Device Handling Problem 1 1
No Apparent Adverse Event 1 1
Appropriate Device Problem Term/Code Not Available 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Tooth Fracture 18 18
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 14 14
Pain 9 9
Insufficient Information 8 8
No Clinical Signs, Symptoms or Conditions 7 7
Choking 5 5
Hypersensitivity/Allergic reaction 2 2
Foreign Body In Patient 2 2
Deformity/ Disfigurement 2 2
Speech Disorder 1 1
Unspecified Musculoskeletal problem 1 1
Discomfort 1 1
Hemorrhage/Blood Loss/Bleeding 1 1
Abscess 1 1
Bruxism 1 1
Joint Contracture 1 1
Sensitivity of Teeth 1 1

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