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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
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 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
FUSELIER ENTERPRISES, LLC
  SUBSTANTIALLY EQUIVALENT 1
GREYSTONE IP LTD
  SUBSTANTIALLY EQUIVALENT 1
INSERT MOLDING SOLUTIONS, INC.
  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 2
PANTHERA DENTAL INC.
  SUBSTANTIALLY EQUIVALENT 1
PASSION FOR LIFE HEALTHCARE (UK) LIMITED
  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. (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

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 121 121
Break 29 29
Insufficient Information 26 26
Patient Device Interaction Problem 15 15
Detachment Of Device Component 13 13
Biocompatibility 12 12
Detachment of Device or Device Component 11 11
Crack 9 9
Patient-Device Incompatibility 9 9
Material Separation 6 6
Material Integrity Problem 6 6
Inadequacy of Device Shape and/or Size 5 5
Device Operates Differently Than Expected 4 4
Material Split, Cut or Torn 4 4
Loose or Intermittent Connection 4 4
Fitting Problem 3 3
Device Fell 3 3
Defective Component 2 2
Unintended Movement 2 2
Fracture 2 2
Component Falling 2 2
Malposition of Device 1 1
Chemical Problem 1 1
Separation Problem 1 1
Device Slipped 1 1
Stretched 1 1
Failure to Align 1 1
Split 1 1
Deformation Due to Compressive Stress 1 1
Device Dislodged or Dislocated 1 1
Therapeutic or Diagnostic Output Failure 1 1
Collapse 1 1
Material Fragmentation 1 1
Material Protrusion/Extrusion 1 1
Material Deformation 1 1
Improper or Incorrect Procedure or Method 1 1
Corroded 1 1
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypersensitivity/Allergic reaction 75 75
Reaction 55 55
No Known Impact Or Consequence To Patient 46 46
Swelling 25 25
Pain 18 18
Discomfort 13 13
Erythema 11 11
Rash 10 10
No Information 9 9
Inflammation 8 8
Irritation 7 7
Insufficient Information 6 6
Burning Sensation 6 6
Tooth Fracture 5 5
No Code Available 5 5
Tingling 4 4
Foreign Body In Patient 4 4
Choking 4 4
No Clinical Signs, Symptoms or Conditions 4 4
Ulcer 4 4
Peeling 3 3
Numbness 3 3
Post Operative Wound Infection 3 3
Itching Sensation 3 3
Aspiration/Inhalation 3 3
Sensitivity of Teeth 3 3
Swelling/ Edema 2 2
Unspecified Infection 2 2
No Consequences Or Impact To Patient 2 2
Fungal Infection 1 1
Sleep Dysfunction 1 1
Partial thickness (Second Degree) Burn 1 1
Contact Dermatitis 1 1
Pressure Sores 1 1
Toxicity 1 1
Joint Dislocation 1 1
Therapeutic Effects, Unexpected 1 1
Fever 1 1
Failure of Implant 1 1
Diarrhea 1 1
Headache 1 1
Chest Tightness/Pressure 1 1
Patient Problem/Medical Problem 1 1
Chemical Exposure 1 1
Apnea 1 1
Bronchitis 1 1
Local Reaction 1 1
Localized Skin Lesion 1 1
Unspecified Tissue Injury 1 1
Low Oxygen Saturation 1 1
Reaction to Medicinal Component of Device 1 1
Ulceration 1 1
Wheal(s) 1 1
Burn(s) 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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