SUNI MAX

Handpiece, Air-powered, Dental

SATELEC

The following data is part of a premarket notification filed by Satelec with the FDA for Suni Max.

Pre-market Notification Details

Device IDK000049
510k NumberK000049
Device Name:SUNI MAX
ClassificationHandpiece, Air-powered, Dental
Applicant SATELEC 70 WALNUT ST. Wellesley,  MA  02481
ContactJacqueline E Masse
CorrespondentJacqueline E Masse
SATELEC 70 WALNUT ST. Wellesley,  MA  02481
Product CodeEFB  
CFR Regulation Number872.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-01-07
Decision Date2000-04-04

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