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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
Product CodeLRK
Regulation Number 872.5570
Device Class 2


Premarket Reviews
ManufacturerDecision
AIRWAY MANAGEMENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
ALLEN J. MOSES, DDS LTD
  SUBSTANTIALLY EQUIVALENT 1
ALWAYS MORE MARKETING
  SUBSTANTIALLY EQUIVALENT 1
AMERICAN SLEEP DENTISTRY
  SUBSTANTIALLY EQUIVALENT 1
APNEA SCIENCES COPORATION
  SUBSTANTIALLY EQUIVALENT 1
APNEA SCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
APNOMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
B. FAREID, DDS, PC
  SUBSTANTIALLY EQUIVALENT 1
BLUESOM
  SUBSTANTIALLY EQUIVALENT 1
COMFORT ACRYLICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CRANE DENTAL LABORATORY, INC
  SUBSTANTIALLY EQUIVALENT 1
DASOFT PARTNERS
  SUBSTANTIALLY EQUIVALENT 2
DENTAL CHOICE HOLDINGS LLC
  SUBSTANTIALLY EQUIVALENT 1
DIAMOND ORTHOTIC LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
EMA SLEEP INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
FIRMA INGEMARSSON
  SUBSTANTIALLY EQUIVALENT 1
FISSIONTECH LLC
  SUBSTANTIALLY EQUIVALENT 1
FUSELIER ENTERPRISES, 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
INSERT MOLDING SOLUTIONS, INC.
  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
MICHAEL D WILLIAMS DDS PA
  SUBSTANTIALLY EQUIVALENT 1
MOSES APPLIANCES LLC
  SUBSTANTIALLY EQUIVALENT 1
MPOWRX HEALTH AND WELLNESS PRODUCTS 2012 INC
  SUBSTANTIALLY EQUIVALENT 1
ORTHOAPNEA S.L.
  SUBSTANTIALLY EQUIVALENT 2
OSCIMED SA
  SUBSTANTIALLY EQUIVALENT 1
OVENTUS MANUFACTURING PTY LTD
  SUBSTANTIALLY EQUIVALENT 4
PANTHERA DENTAL INC.
  SUBSTANTIALLY EQUIVALENT 1
PASSION FOR LIFE HEALTHCARE (UK) LIMITED
  SUBSTANTIALLY EQUIVALENT 1
PRISMATIK DENTALCRAFT, INC
  SUBSTANTIALLY EQUIVALENT 1
PRISMATIK DENTALCRAFT, INC.
  SUBSTANTIALLY EQUIVALENT 3
PROSOMNUS SLEEP TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
PROSOMNUS SLEEP TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
RESPIRE MEDICAL HOLDING
  SUBSTANTIALLY EQUIVALENT 1
RESPIRE MEDICAL HOLDINGS
  SUBSTANTIALLY EQUIVALENT 1
RESPIRE MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
S4S UK LTD.
  SUBSTANTIALLY EQUIVALENT 1
SAS ONIRIS
  SUBSTANTIALLY EQUIVALENT 1
SCOPE HEALTHCARE TECHNOLOGIES PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
SHINRIN-YOKU TRADERS LLC
  SUBSTANTIALLY EQUIVALENT 1
SICAT GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
SKETCHPAD INNOVATIONS LLC
  SUBSTANTIALLY EQUIVALENT 1
SLEEP SCIENCE PARTNERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SLEEPING WELL, 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
SOMNICS INC.
  SUBSTANTIALLY EQUIVALENT 1
SOMNOMED INC.
  SUBSTANTIALLY EQUIVALENT 2
STEPHEN J HARKINS, DDS, PC
  SUBSTANTIALLY EQUIVALENT 1
THE CENTER FOR CRANIOFACIAL & DENTAL SLEEP MEDICINE
  SUBSTANTIALLY EQUIVALENT 1
THE SNORE RELIEVER COMPANY, LLC
  SUBSTANTIALLY EQUIVALENT 1
THE TMJ CLINIC, PC.
  SUBSTANTIALLY EQUIVALENT 1
TRUE FUNCTION LABORATORY, INC.
  SUBSTANTIALLY EQUIVALENT 2
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 2
ZEPHYR SLEEP TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 18 18
2017 32 32
2018 61 61
2019 56 56
2020 24 24
2021 49 49
2022 40 40
2023 50 50
2024 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 131 131
Insufficient Information 53 53
Break 40 40
Patient Device Interaction Problem 32 32
Biocompatibility 29 29
Detachment Of Device Component 14 14
Patient-Device Incompatibility 13 13
Detachment of Device or Device Component 11 11
Crack 9 9
Material Integrity Problem 8 8
Material Separation 7 7
Inadequacy of Device Shape and/or Size 6 6
Loose or Intermittent Connection 5 5
Use of Device Problem 4 4
Device Operates Differently Than Expected 4 4
Material Split, Cut or Torn 4 4
Device Fell 3 3
Fitting Problem 3 3
Component Falling 3 3
Fracture 2 2
Material Fragmentation 2 2
Product Quality Problem 2 2
Device Slipped 2 2
Defective Component 2 2
Malposition of Device 2 2
Unintended Movement 2 2
Material Protrusion/Extrusion 1 1
Separation Problem 1 1
Deformation Due to Compressive Stress 1 1
Chemical Problem 1 1
Failure to Align 1 1
Split 1 1
Device Dislodged or Dislocated 1 1
Extrusion 1 1
Material Deformation 1 1
Output Problem 1 1
Protective Measures Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Stretched 1 1
Device Appears to Trigger Rejection 1 1
Improper or Incorrect Procedure or Method 1 1
Device Reprocessing Problem 1 1
Collapse 1 1
Use of Incorrect Control/Treatment Settings 1 1
Corroded 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypersensitivity/Allergic reaction 124 124
Reaction 55 55
No Known Impact Or Consequence To Patient 50 50
Swelling 25 25
Pain 21 21
Discomfort 17 17
No Information 12 12
Erythema 11 11
Rash 10 10
No Clinical Signs, Symptoms or Conditions 10 10
Irritation 9 9
Inflammation 8 8
No Code Available 7 7
Burning Sensation 7 7
Tooth Fracture 6 6
Insufficient Information 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Tingling 4 4
Choking 4 4
Ulcer 4 4
Foreign Body In Patient 4 4
Aspiration/Inhalation 3 3
Sensitivity of Teeth 3 3
No Consequences Or Impact To Patient 3 3
Sleep Dysfunction 3 3
Peeling 3 3
Post Operative Wound Infection 3 3
Swelling/ Edema 3 3
Numbness 3 3
Itching Sensation 3 3
Unspecified Infection 3 3
Joint Dislocation 2 2
Failure of Implant 2 2
Myalgia 2 2
Localized Skin Lesion 2 2
Tissue Damage 2 2
Chemical Exposure 1 1
Unspecified Tissue Injury 1 1
Loss of Range of Motion 1 1
Reaction to Medicinal Component of Device 1 1
Burn(s) 1 1
Contact Dermatitis 1 1
Therapeutic Effects, Unexpected 1 1
Anxiety 1 1
Chest Tightness/Pressure 1 1
Headache 1 1
Device Embedded In Tissue or Plaque 1 1
Diarrhea 1 1
Neck Pain 1 1
Fungal Infection 1 1
Toxicity 1 1
Fever 1 1
Pressure Sores 1 1
Partial thickness (Second Degree) Burn 1 1
Apnea 1 1
Local Reaction 1 1
Weight Changes 1 1
Bronchitis 1 1
Patient Problem/Medical Problem 1 1
Wheal(s) 1 1
Ulceration 1 1
Low Oxygen Saturation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Dental Choice Holding Llc II Aug-02-2022
2 Respire Medical II May-29-2018
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