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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
AKERVALL TECHNOLOGIES INC
  SUBSTANTIALLY EQUIVALENT 1
BITE TECH INC.
  SUBSTANTIALLY EQUIVALENT 1
BOYD RESEARCH, INC.
  SUBSTANTIALLY EQUIVALENT 2
DENTAL ARTE, INC.
  SUBSTANTIALLY EQUIVALENT 1
DENTAL CHOICE HOLDINGS, LLC
  SUBSTANTIALLY EQUIVALENT 1
DENTEK ORAL CARE, INC.
  SUBSTANTIALLY EQUIVALENT 3
DOC BRANDS, INC.
  SUBSTANTIALLY EQUIVALENT 1
FBCC INC
  SUBSTANTIALLY EQUIVALENT 1
GRIND GUARD TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL PROFIT BUILDERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
KONCEPT INNOVATORS, LLC.
  SUBSTANTIALLY EQUIVALENT 1
MCKEON PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
MEDTECH PRODUCTS INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTECH PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORALABS, INC.
  SUBSTANTIALLY EQUIVALENT 1
POWER PRODUCTS, INC.-SPLINTEK
  SUBSTANTIALLY EQUIVALENT 1
RANIR CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
RANIR LLC
  SUBSTANTIALLY EQUIVALENT 5
REAZEAL CORP
  SUBSTANTIALLY EQUIVALENT 1
SLEEP SPECIALTIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
SPLINTEK, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2014 776 776
2015 31 31
2016 16 16
2017 24 24
2018 23 23
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
Delamination 698 698
Material Separation 39 39
Break 31 31
Adverse Event Without Identified Device or Use Problem 28 28
Insufficient Information 19 19
Patient-Device Incompatibility 18 18
Detachment Of Device Component 15 15
Device Operates Differently Than Expected 13 13
Fitting Problem 13 13
Split 8 8
Improper or Incorrect Procedure or Method 7 7
Product Quality Problem 6 6
Material Integrity Problem 6 6
Inadequacy of Device Shape and/or Size 5 5
Crack 4 4
Material Disintegration 4 4
Entrapment of Device 4 4
Material Fragmentation 4 4
Use of Device Problem 4 4
Component Missing 4 4
Torn Material 4 4
Appropriate Term/Code Not Available 3 3
Material Split, Cut or Torn 3 3
Unexpected Therapeutic Results 3 3
Detachment of Device or Device Component 3 3
Component Falling 3 3
Peeled/Delaminated 2 2
Off-Label Use 2 2
Device Slipped 2 2
Air Leak 2 2
Device Or Device Fragments Location Unknown 2 2
Malposition of Device 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Material Distortion 1 1
Device Damaged by Another Device 1 1
Human-Device Interface Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Unstable 1 1
Tear, Rip or Hole in Device Packaging 1 1
Structural Problem 1 1
Hole In Material 1 1
Migration or Expulsion of Device 1 1
Device Emits Odor 1 1
Fail-Safe Design Failure 1 1
Device Fell 1 1
Separation Problem 1 1
Misassembly by Users 1 1
No Apparent Adverse Event 1 1
Naturally Worn 1 1
Output Problem 1 1
Physical Property Issue 1 1
Scratched Material 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 796 796
No Code Available 24 24
Swelling 17 17
Pain 16 16
Reaction 12 12
Foreign Body In Patient 12 12
No Information 12 12
Choking 9 9
Discomfort 7 7
Tooth Fracture 6 6
Insufficient Information 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Hypersensitivity/Allergic reaction 5 5
Irritation 5 5
Complaint, Ill-Defined 4 4
Deformity/ Disfigurement 4 4
No Clinical Signs, Symptoms or Conditions 3 3
Injury 3 3
Unspecified Infection 3 3
Rash 3 3
Abdominal Pain 2 2
Laceration(s) 2 2
Burning Sensation 2 2
Skin Inflammation 2 2
Sensitivity of Teeth 2 2
Patient Problem/Medical Problem 2 2
Abdominal Distention 1 1
Sweating 1 1
Tingling 1 1
No Consequences Or Impact To Patient 1 1
Stenosis 1 1
Therapeutic Response, Decreased 1 1
Anxiety 1 1
Nausea 1 1
Abrasion 1 1
Chest Pain 1 1
Diarrhea 1 1
Dyspnea 1 1
Erythema 1 1
Hemorrhage/Bleeding 1 1
Inflammation 1 1
Itching Sensation 1 1
Increased Sensitivity 1 1
Skin Discoloration 1 1
Skin Irritation 1 1
Tachycardia 1 1
Therapeutic Effects, Unexpected 1 1
Tissue Damage 1 1
Joint Contracture 1 1

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