TEMPOREX

Material, Tooth Shade, Resin

SCIENTIFIC PHARMACEUTICALS, INC.

The following data is part of a premarket notification filed by Scientific Pharmaceuticals, Inc. with the FDA for Temporex.

Pre-market Notification Details

Device IDK903551
510k NumberK903551
Device Name:TEMPOREX
ClassificationMaterial, Tooth Shade, Resin
Applicant SCIENTIFIC PHARMACEUTICALS, INC. 1828 EVERGREEN ST. Duarte,  CA  91010
ContactJan A Orlowski
CorrespondentJan A Orlowski
SCIENTIFIC PHARMACEUTICALS, INC. 1828 EVERGREEN ST. Duarte,  CA  91010
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-08-06
Decision Date1990-10-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817051020044 K903551 000
D801SP50601B1 K903551 000
D801SP50601N1 K903551 000
D801SP50602B1 K903551 000
D801SP50602N1 K903551 000
D801SP50603B1 K903551 000
D801SP50603N1 K903551 000
D801SP5060S1 K903551 000
00850015110344 K903551 000
00816526021265 K903551 000
00817051020037 K903551 000
D801SP50601 K903551 000

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