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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
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 1
EL.EN. ELECTRONIC ENGINEERING SPA
  SUBSTANTIALLY EQUIVALENT 1
GIGAALASER COMPANY LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD.
  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

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