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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device laser, dental, soft tissue
Regulation Description Laser surgical instrument for use in general and plastic surgery and in dermatology.
Definition Intended for the incision, excision, cutting, ablation, and vaporization of soft tissue in oral and maxillofacial surgery and dentistry.
Product CodeNVK
Regulation Number 878.4810
Device Class 2


Premarket Reviews
ManufacturerDecision
AZENA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
BIOLASE, INC.
  SUBSTANTIALLY EQUIVALENT 1
CONVERGENT DENTAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
DENTLIGHT, INC.
  SUBSTANTIALLY EQUIVALENT 1
EL.EN ELECTRONIC ENGINEERING SPA
  SUBSTANTIALLY EQUIVALENT 2
GIGAALASER COMPANY , LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MATELASER, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDENCY S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI WONDERFUL OPTO-ELECTRICS TECH.CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN SOGA TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
WUHAN PIOON TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K243764  Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UT ...

MDR Year MDR Reports MDR Events
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Nerve Damage 1 1
Loss of Range of Motion 1 1
Numbness 1 1
Unspecified Heart Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Convergent Dental II Nov-17-2023
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