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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
APNEA SCIENCES COPORATION
  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
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
OVENTUS MANUFACTURING PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
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 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 SNORE RELIEVER COMPANY, LLC
  SUBSTANTIALLY EQUIVALENT 1
THE TMJ CLINIC, PC.
  SUBSTANTIALLY EQUIVALENT 1
TRUE FUNCTION LABORATORY, 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
2018 61 61
2019 56 56
2020 24 24
2021 49 49
2022 40 40
2023 32 32

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 117 117
Insufficient Information 42 42
Break 23 23
Patient Device Interaction Problem 20 20
Biocompatibility 17 17
Detachment of Device or Device Component 11 11
Patient-Device Incompatibility 10 10
Crack 9 9
Material Separation 5 5
Inadequacy of Device Shape and/or Size 5 5
Detachment Of Device Component 5 5
Material Integrity Problem 5 5
Material Split, Cut or Torn 4 4
Device Fell 3 3
Use of Device Problem 3 3
Fitting Problem 2 2
Defective Component 2 2
Loose or Intermittent Connection 2 2
Deformation Due to Compressive Stress 1 1
Failure to Align 1 1
Malposition of Device 1 1
Use of Incorrect Control/Treatment Settings 1 1
Corroded 1 1
Collapse 1 1
Device Slipped 1 1
Fracture 1 1
Material Fragmentation 1 1
Separation Problem 1 1
Material Protrusion/Extrusion 1 1
Device Operates Differently Than Expected 1 1
Device Dislodged or Dislocated 1 1
Material Deformation 1 1
Output Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Unintended Movement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypersensitivity/Allergic reaction 101 101
Reaction 48 48
No Known Impact Or Consequence To Patient 38 38
Swelling 23 23
Pain 19 19
Discomfort 12 12
Erythema 11 11
Rash 10 10
Inflammation 8 8
Irritation 7 7
No Information 7 7
Insufficient Information 6 6
Burning Sensation 5 5
Tooth Fracture 5 5
Choking 4 4
Tingling 4 4
Ulcer 4 4
No Clinical Signs, Symptoms or Conditions 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Swelling/ Edema 3 3
Numbness 3 3
Itching Sensation 3 3
Peeling 3 3
Aspiration/Inhalation 2 2
Unspecified Infection 2 2
Foreign Body In Patient 2 2
Sensitivity of Teeth 2 2
No Code Available 2 2
Localized Skin Lesion 2 2
Contact Dermatitis 1 1
Unspecified Tissue Injury 1 1
Reaction to Medicinal Component of Device 1 1
Patient Problem/Medical Problem 1 1
Partial thickness (Second Degree) Burn 1 1
Sleep Dysfunction 1 1
Weight Changes 1 1
Fungal Infection 1 1
Joint Dislocation 1 1
Pressure Sores 1 1
Wheal(s) 1 1
Apnea 1 1
Failure of Implant 1 1
Burn(s) 1 1
Headache 1 1
Local Reaction 1 1
Ulceration 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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