SDI COMPOSTIES

Material, Tooth Shade, Resin

SOUTHERN DENTAL INDUSTRIES, INC.

The following data is part of a premarket notification filed by Southern Dental Industries, Inc. with the FDA for Sdi Composties.

Pre-market Notification Details

Device IDK941899
510k NumberK941899
Device Name:SDI COMPOSTIES
ClassificationMaterial, Tooth Shade, Resin
Applicant SOUTHERN DENTAL INDUSTRIES, INC. 7020 KOLL CENTER PKWY. SUITE 140 Pleasanton,  CA  94566
ContactJudy Hagenbaugh
CorrespondentJudy Hagenbaugh
SOUTHERN DENTAL INDUSTRIES, INC. 7020 KOLL CENTER PKWY. SUITE 140 Pleasanton,  CA  94566
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-04-19
Decision Date1994-07-05

NIH GUDID Devices

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