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TPLC
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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 Code
NVK
Regulation Number
878.4810
Device Class
2
Premarket Reviews
Manufacturer
Decision
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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