Stela Automix System

Material, Tooth Shade, Resin

SDI Limited

The following data is part of a premarket notification filed by Sdi Limited with the FDA for Stela Automix System.

Pre-market Notification Details

Device IDK222581
510k NumberK222581
Device Name:Stela Automix System
ClassificationMaterial, Tooth Shade, Resin
Applicant SDI Limited 3-15 Brunsdon Street, Bayswater Melbourne,  AU 3153
ContactQuynh Jewell
CorrespondentQuynh Jewell
SDI Limited 3-15 Brunsdon Street, Bayswater Melbourne,  AU 3153
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-08-26
Decision Date2022-10-28

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