SIROLaser Blue

Powered Laser Surgical Instrument

Dentsply Sirona

The following data is part of a premarket notification filed by Dentsply Sirona with the FDA for Sirolaser Blue.

Pre-market Notification Details

Device IDK180044
501k NumberK180044
Device Name:SIROLaser Blue
ClassificationPowered Laser Surgical Instrument
Applicant Dentsply Sirona 221 West Philadelphia Street Suite 60W York,  PA  17401
ContactKarl J Nittinger
CorrespondentKarl J Nittinger
Dentsply Sirona 221 West Philadelphia Street Suite 60W York,  PA  17401
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral & Plastic Surgery
501k Review PanelGeneral & Plastic Surgery
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-01-08
Decision Date2018-03-08
Summary:summary

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.