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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
AIOMEGA, LLC
  SUBSTANTIALLY EQUIVALENT 1
AIRWAY TECHNOLOGIES D/B/A AIRWAY MANAGEMENT
  SUBSTANTIALLY EQUIVALENT 1
APNEA SCIENCES COPORATION
  SUBSTANTIALLY EQUIVALENT 1
DASOFT PARTNERS
  SUBSTANTIALLY EQUIVALENT 1
DCSTAR INC
  SUBSTANTIALLY EQUIVALENT 1
DENTAL CHOICE HOLDINGS LLC
  SUBSTANTIALLY EQUIVALENT 1
DIAMOND ORTHOTIC LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
DONGGUAN YIYAO SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
EMA SLEEP INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
FISSIONTECH LLC
  SUBSTANTIALLY EQUIVALENT 3
GELB PRACTICE SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GOOD SLEEP CO PTE LTD.
  SUBSTANTIALLY EQUIVALENT 2
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
NIGHTGUARD EXPRESS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ONIRIS
  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
SPLINTEK INC.
  SUBSTANTIALLY EQUIVALENT 1
THE SNORE RELIEVER COMPANY, LLC
  SUBSTANTIALLY EQUIVALENT 1
THE TMJ CLINIC PC
  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 25
2021 49 49
2022 40 40
2023 50 50
2024 185 185
2025 482 482

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 386 386
Break 350 350
Adverse Event Without Identified Device or Use Problem 92 92
Insufficient Information 57 57
Patient Device Interaction Problem 51 51
Fracture 43 43
Biocompatibility 30 30
Material Integrity Problem 11 11
Patient-Device Incompatibility 9 10
Crack 5 5
Inadequacy of Device Shape and/or Size 5 5
Use of Device Problem 4 4
Material Separation 4 4
Therapeutic or Diagnostic Output Failure 3 3
Material Fragmentation 3 3
Failure to Osseointegrate 3 3
Device Slipped 1 1
Fitting Problem 1 1
Separation Problem 1 1
Mechanical Problem 1 1
Output Problem 1 1
Device Damaged by Another Device 1 1
Lack of Effect 1 1
Use of Incorrect Control/Treatment Settings 1 1
Loss of or Failure to Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 528 528
Hypersensitivity/Allergic reaction 128 128
Insufficient Information 99 99
Pain 28 28
Discomfort 14 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 13 13
Swelling/ Edema 11 11
Inflammation 8 8
Burning Sensation 8 8
Tooth Fracture 5 5
Reaction 5 5
Rash 5 5
Unspecified Infection 4 4
Ulcer 4 4
Swelling 4 4
Dry Mouth 3 3
No Known Impact Or Consequence To Patient 3 3
Choking 3 3
Erythema 3 3
Sensitivity of Teeth 2 3
Itching Sensation 2 2
Local Reaction 2 2
Myalgia 2 2
Blister 2 2
Localized Skin Lesion 2 2
Skin Burning Sensation 1 1
Inadequate Pain Relief 1 1
Headache 1 1
Partial thickness (Second Degree) Burn 1 1
Unspecified Tissue Injury 1 1
Contact Dermatitis 1 1
Bruxism 1 1
Laceration(s) 1 1
Dyspnea 1 1
Numbness 1 1
Loss of Range of Motion 1 1
Stenosis of the esophagus 1 1
Foreign Body In Patient 1 1
Irritation 1 1
Fever 1 1
Reaction to Medicinal Component of Device 1 1
Aspiration/Inhalation 1 1
Fungal Infection 1 1
Failure of Implant 1 1
Joint Dislocation 1 1
Tingling 1 1
Apnea 1 2
Difficulty Chewing 1 1
Patient Problem/Medical Problem 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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