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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
ALWAYS MORE MARKETING
  SUBSTANTIALLY EQUIVALENT 1
AMERICAN SLEEP DENTISTRY
  SUBSTANTIALLY EQUIVALENT 1
APNEA SCIENCES COPORATION
  SUBSTANTIALLY EQUIVALENT 1
APNEA SCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
APNOMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
B. FAREID, DDS, PC
  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
FISSIONTECH LLC
  SUBSTANTIALLY EQUIVALENT 1
FUSELIER ENTERPRISES, LLC
  SUBSTANTIALLY EQUIVALENT 1
GELB PRACTICE SOLUTIONS, INC.
  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 2
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
SCOPE HEALTHCARE TECHNOLOGIES PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
SHINRIN-YOKU TRADERS LLC
  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
SOMNOMED INC.
  SUBSTANTIALLY EQUIVALENT 1
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
2017 32 32
2018 61 61
2019 56 56
2020 24 24
2021 49 49
2022 40 40
2023 50 50
2024 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 129 129
Insufficient Information 51 51
Break 33 33
Patient Device Interaction Problem 32 32
Biocompatibility 29 29
Detachment Of Device Component 13 13
Patient-Device Incompatibility 11 11
Detachment of Device or Device Component 11 11
Crack 9 9
Material Integrity Problem 8 8
Material Separation 6 6
Inadequacy of Device Shape and/or Size 5 5
Loose or Intermittent Connection 4 4
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
Defective Component 2 2
Unintended Movement 2 2
Fracture 2 2
Component Falling 2 2
Use of Incorrect Control/Treatment Settings 1 1
Corroded 1 1
Material Fragmentation 1 1
Collapse 1 1
Improper or Incorrect Procedure or Method 1 1
Product Quality Problem 1 1
Device Slipped 1 1
Stretched 1 1
Output Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Material Protrusion/Extrusion 1 1
Deformation Due to Compressive Stress 1 1
Chemical Problem 1 1
Failure to Align 1 1
Split 1 1
Malposition of Device 1 1
Device Dislodged or Dislocated 1 1
Material Deformation 1 1
Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypersensitivity/Allergic reaction 122 122
Reaction 55 55
No Known Impact Or Consequence To Patient 46 46
Swelling 25 25
Pain 19 19
Discomfort 15 15
Erythema 11 11
Rash 10 10
No Clinical Signs, Symptoms or Conditions 10 10
No Information 9 9
Inflammation 8 8
Irritation 7 7
Burning Sensation 7 7
Insufficient Information 6 6
No Code Available 5 5
Tooth Fracture 5 5
Choking 4 4
Tingling 4 4
Ulcer 4 4
Foreign Body In Patient 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Sensitivity of Teeth 3 3
Swelling/ Edema 3 3
Post Operative Wound Infection 3 3
Numbness 3 3
Itching Sensation 3 3
Peeling 3 3
Aspiration/Inhalation 3 3
Unspecified Infection 2 2
No Consequences Or Impact To Patient 2 2
Myalgia 2 2
Sleep Dysfunction 2 2
Localized Skin Lesion 2 2
Contact Dermatitis 1 1
Unspecified Tissue Injury 1 1
Reaction to Medicinal Component of Device 1 1
Chemical Exposure 1 1
Weight Changes 1 1
Patient Problem/Medical Problem 1 1
Partial thickness (Second Degree) Burn 1 1
Wheal(s) 1 1
Pressure Sores 1 1
Therapeutic Effects, Unexpected 1 1
Ulceration 1 1
Fungal Infection 1 1
Toxicity 1 1
Joint Dislocation 1 1
Chest Tightness/Pressure 1 1
Low Oxygen Saturation 1 1
Apnea 1 1
Loss of Range of Motion 1 1
Local Reaction 1 1
Bronchitis 1 1
Burn(s) 1 1
Diarrhea 1 1
Fever 1 1
Headache 1 1
Failure of Implant 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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