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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
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 3
GREYSTONE IP, LTD.
  SUBSTANTIALLY EQUIVALENT 1
INNOVATIVE HEALTH TECHNOLOGIES (NZ), LTD.
  SUBSTANTIALLY EQUIVALENT 1
ISLAND DENTAL LAB, INC DBA EMERALD DENTAL
  SUBSTANTIALLY EQUIVALENT 1
MERIS INVESTMENT GROUP
  SUBSTANTIALLY EQUIVALENT 1
MYOFUNCTIONAL RESEARCH CO.
  SUBSTANTIALLY EQUIVALENT 1
NIGHTGUARD EXPRESS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ONIRIS
  SUBSTANTIALLY EQUIVALENT 1
ORTHOAPNEA S.L.
  SUBSTANTIALLY EQUIVALENT 2
OSCIMED SA
  SUBSTANTIALLY EQUIVALENT 1
PARK DENTAL RESEARCH CORP.
  SUBSTANTIALLY EQUIVALENT 1
PRISMATIK DENTALCRAFT, INC.
  SUBSTANTIALLY EQUIVALENT 3
PROSOMNUS SLEEP TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
QUIETLAB, LLC
  SUBSTANTIALLY EQUIVALENT 1
RAM.SHAW PTE. , LTD.
  SUBSTANTIALLY EQUIVALENT 1
RESPIRE MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
S4S UK , LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHAEFERH, LLC
  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 2
VIVOS THERAPEUTICS
  SUBSTANTIALLY EQUIVALENT 1
VIVOS THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
VIVOS THERAPEUTICS, INC. (FORMERLY VIVOS BIOTECHNOLOGIES, I)
  SUBSTANTIALLY EQUIVALENT 1
ZELEGENT, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 49 49
2022 40 40
2023 50 50
2024 185 185
2025 660 660
2026 397 397

Device Problems MDRs with this Device Problem Events in those MDRs
Break 751 751
Detachment of Device or Device Component 499 499
Fracture 105 105
Adverse Event Without Identified Device or Use Problem 101 101
Patient Device Interaction Problem 60 60
Insufficient Information 58 58
Biocompatibility 33 33
Crack 13 13
Material Integrity Problem 12 12
Patient-Device Incompatibility 10 10
Material Fragmentation 9 9
Fitting Problem 6 6
Inadequacy of Device Shape and/or Size 5 5
Physical Resistance/Sticking 4 4
Use of Device Problem 4 4
Material Separation 4 4
Therapeutic or Diagnostic Output Failure 3 3
Failure to Osseointegrate 3 3
No Apparent Adverse Event 3 3
Device Damaged by Another Device 2 2
Device Slipped 1 1
Separation Problem 1 1
Mechanical Problem 1 1
Output Problem 1 1
Failure to Transmit Record 1 1
Defective Device 1 1
Scratched Material 1 1
Sharp Edges 1 1
Lack of Effect 1 1
Use of Incorrect Control/Treatment Settings 1 1
Packaging Problem 1 1
Data Problem 1 1
Protective Measures Problem 1 1
Loss of or Failure to Bond 1 1
Loss of Osseointegration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 962 962
Insufficient Information 235 235
Hypersensitivity/Allergic reaction 132 132
Pain 45 45
Discomfort 22 22
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 17 17
Swelling/ Edema 14 14
Burning Sensation 8 8
Inflammation 8 8
Unspecified Infection 6 6
Tooth Fracture 6 6
Localized Skin Lesion 5 5
Skin Inflammation/ Irritation 5 5
Rash 4 4
Dyspnea 4 4
Choking 4 4
Headache 4 4
Dry Mouth 3 3
Sensitivity of Teeth 3 3
Abrasion 2 2
Itching Sensation 2 2
Local Reaction 2 2
Myalgia 2 2
Failure of Implant 2 2
Blister 2 2
Foreign Body In Patient 2 2
Erythema 2 2
Unspecified Tissue Injury 2 2
Ulcer 2 2
Fungal Infection 1 1
Aspiration/Inhalation 1 1
Decreased Sensitivity 1 1
Anaphylactoid 1 1
Reaction to Medicinal Component of Device 1 1
Joint Dislocation 1 1
Burn(s) 1 1
Fever 1 1
Stenosis of the esophagus 1 1
Difficulty Chewing 1 1
Loss of Range of Motion 1 1
Numbness 1 1
Weight Changes 1 1
Laceration(s) 1 1
Sleep Dysfunction 1 1
Bruxism 1 1
Contact Dermatitis 1 1
Inadequate Pain Relief 1 1
Fibrosis 1 1
Stomatitis 1 1
Increased Sensitivity 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Dental Choice Holding Llc II Aug-02-2022
2 Myofunctional Research Company USA II Dec-18-2025
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