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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, anti-snoring
Regulation Description Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
Product CodeLRK
Regulation Number 872.5570
Device Class 2


Premarket Reviews
ManufacturerDecision
APNEA SCIENCES COPORATION
  SUBSTANTIALLY EQUIVALENT 1
DASOFT PARTNERS
  SUBSTANTIALLY EQUIVALENT 1
DENTAL CHOICE HOLDINGS LLC
  SUBSTANTIALLY EQUIVALENT 1
DIAMOND ORTHOTIC LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
EMA SLEEP INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
FISSIONTECH LLC
  SUBSTANTIALLY EQUIVALENT 1
GELB PRACTICE SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GOOD SLEEP CO PTE LTD.
  SUBSTANTIALLY EQUIVALENT 1
GREYSTONE IP LTD
  SUBSTANTIALLY EQUIVALENT 1
INNOVATIVE HEALTH TECHNOLOGIES (NZ), LTD
  SUBSTANTIALLY EQUIVALENT 1
ISLAND DENTAL LAB, INC DBA EMERALD DENTAL
  SUBSTANTIALLY EQUIVALENT 1
KONCEPT INNOVATORS, LLC.
  SUBSTANTIALLY EQUIVALENT 1
MERIS INVESTMENT GROUP
  SUBSTANTIALLY EQUIVALENT 1
MPOWRX HEALTH AND WELLNESS PRODUCTS 2012 INC
  SUBSTANTIALLY EQUIVALENT 1
ORTHOAPNEA S.L.
  SUBSTANTIALLY EQUIVALENT 2
OSCIMED SA
  SUBSTANTIALLY EQUIVALENT 1
PRISMATIK DENTALCRAFT, INC
  SUBSTANTIALLY EQUIVALENT 1
PRISMATIK DENTALCRAFT, INC.
  SUBSTANTIALLY EQUIVALENT 2
PROSOMNUS SLEEP TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
PROSOMNUS SLEEP TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
RESPIRE MEDICAL HOLDINGS
  SUBSTANTIALLY EQUIVALENT 1
RESPIRE MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
S4S UK LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHINRIN-YOKU TRADERS LLC
  SUBSTANTIALLY EQUIVALENT 1
SLEEPING WELL, LLC
  SUBSTANTIALLY EQUIVALENT 1
SMARTGUARD RX INC.
  SUBSTANTIALLY EQUIVALENT 1
SNOREBANDIT LLC
  SUBSTANTIALLY EQUIVALENT 1
SOLBARO CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
THE SNORE RELIEVER COMPANY, LLC
  SUBSTANTIALLY EQUIVALENT 1
THE TMJ CLINIC, PC.
  SUBSTANTIALLY EQUIVALENT 1
VIVOS THERAPEUTICS
  SUBSTANTIALLY EQUIVALENT 1
VIVOS THERAPEUTICS, INC
  SUBSTANTIALLY EQUIVALENT 1
VIVOS THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VIVOS THERAPEUTICS, INC. (FORMERLY VIVOS BIOTECHNOLOGIES, I)
  SUBSTANTIALLY EQUIVALENT 1
ZELEGENT, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 24 24
2021 49 49
2022 40 40
2023 50 50
2024 185 185
2025 26 26

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 121 121
Break 84 84
Adverse Event Without Identified Device or Use Problem 76 76
Insufficient Information 55 55
Patient Device Interaction Problem 39 39
Biocompatibility 28 28
Fracture 12 12
Material Integrity Problem 11 11
Patient-Device Incompatibility 6 6
Inadequacy of Device Shape and/or Size 5 5
Use of Device Problem 4 4
Material Fragmentation 2 2
Loss of or Failure to Bond 1 1
Use of Incorrect Control/Treatment Settings 1 1
Therapeutic or Diagnostic Output Failure 1 1
Material Separation 1 1
Separation Problem 1 1
Device Slipped 1 1
Mechanical Problem 1 1
Crack 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 179 179
Hypersensitivity/Allergic reaction 120 120
Pain 19 19
Insufficient Information 19 19
Discomfort 9 9
Inflammation 7 7
Burning Sensation 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Swelling/ Edema 6 6
Reaction 5 5
Rash 5 5
Tooth Fracture 4 4
Swelling 4 4
Ulcer 4 4
No Known Impact Or Consequence To Patient 3 3
Erythema 3 3
Unspecified Infection 3 3
Choking 2 2
Sensitivity of Teeth 2 2
Dry Mouth 2 2
Itching Sensation 2 2
Myalgia 2 2
Localized Skin Lesion 2 2
Sleep Dysfunction 1 1
Fungal Infection 1 1
Numbness 1 1
Joint Dislocation 1 1
Reaction to Medicinal Component of Device 1 1
Unspecified Tissue Injury 1 1
Contact Dermatitis 1 1
Failure of Implant 1 1
Headache 1 1
Aspiration/Inhalation 1 1
Apnea 1 1
Tingling 1 1
Local Reaction 1 1
Loss of Range of Motion 1 1
Laceration(s) 1 1
Irritation 1 1
Partial thickness (Second Degree) Burn 1 1
Patient Problem/Medical Problem 1 1
Foreign Body In Patient 1 1
Weight Changes 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Dental Choice Holding Llc II Aug-02-2022
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