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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, jaw repositioning
Regulation Description Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
Product CodeLQZ
Regulation Number 872.5570
Device Class 2


Premarket Reviews
ManufacturerDecision
ACHAEMENID LLC
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED FACIALDONTICS LLC
  SUBSTANTIALLY EQUIVALENT 1
AIOMEGA, LLC
  SUBSTANTIALLY EQUIVALENT 1
BIOTEX, INC.
  SUBSTANTIALLY EQUIVALENT 1
SLOW WAVE, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 1 1
Device Reprocessing Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 1 1
Swelling/ Edema 1 1
No Consequences Or Impact To Patient 1 1

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