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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
ALWAYS MORE MARKETING
  SUBSTANTIALLY EQUIVALENT 1
APNEA SCIENCES COPORATION
  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 1
DENTAL CHOICE HOLDINGS LLC
  SUBSTANTIALLY EQUIVALENT 1
DIAMOND ORTHOTIC LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
EMA SLEEP INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
FISSIONTECH 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
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
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 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
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
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
  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
ZEPHYR SLEEP TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 56 56
2020 24 24
2021 49 49
2022 40 40
2023 50 50
2024 165 165

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 108 108
Detachment of Device or Device Component 99 99
Break 69 69
Insufficient Information 55 55
Patient Device Interaction Problem 38 38
Biocompatibility 29 29
Material Integrity Problem 12 12
Patient-Device Incompatibility 7 7
Fracture 7 7
Inadequacy of Device Shape and/or Size 6 6
Crack 5 5
Use of Device Problem 4 4
Device Fell 2 2
Material Fragmentation 2 2
Material Separation 2 2
Device Slipped 1 1
Material Split, Cut or Torn 1 1
Separation Problem 1 1
Mechanical Problem 1 1
Output Problem 1 1
Collapse 1 1
Therapeutic or Diagnostic Output Failure 1 1
Failure to Align 1 1
Use of Incorrect Control/Treatment Settings 1 1
Corroded 1 1
Loose or Intermittent Connection 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 140 140
Hypersensitivity/Allergic reaction 122 122
Reaction 23 23
No Known Impact Or Consequence To Patient 22 22
Pain 20 20
Swelling 18 18
Insufficient Information 15 15
Discomfort 11 11
Inflammation 11 11
Erythema 10 10
Rash 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Swelling/ Edema 6 6
Burning Sensation 5 5
Tooth Fracture 5 5
Unspecified Infection 4 4
Ulcer 4 4
Itching Sensation 4 4
Irritation 4 4
Peeling 3 3
Sensitivity of Teeth 2 2
Choking 2 2
Foreign Body In Patient 2 2
Myalgia 2 2
Localized Skin Lesion 2 2
No Information 2 2
Fungal Infection 2 2
Dry Mouth 2 2
Tingling 2 2
Burn(s) 1 1
Local Reaction 1 1
Reaction to Medicinal Component of Device 1 1
Aspiration/Inhalation 1 1
Failure of Implant 1 1
No Code Available 1 1
Numbness 1 1
Loss of Range of Motion 1 1
Apnea 1 1
Joint Dislocation 1 1
Laceration(s) 1 1
Ulceration 1 1
Weight Changes 1 1
Contact Dermatitis 1 1
Unspecified Tissue Injury 1 1
Partial thickness (Second Degree) Burn 1 1
Sleep Dysfunction 1 1
Pressure Sores 1 1
Wheal(s) 1 1
Headache 1 1
Patient Problem/Medical Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Dental Choice Holding Llc II Aug-02-2022
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