INTERFACE - CAVITY LINER

Liner, Cavity, Calcium Hydroxide

SCIENTIFIC PHARMACEUTICALS, INC.

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

Pre-market Notification Details

Device IDK897130
510k NumberK897130
Device Name:INTERFACE - CAVITY LINER
ClassificationLiner, Cavity, Calcium Hydroxide
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 CodeEJK  
CFR Regulation Number872.3250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-12-27
Decision Date1990-03-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850015110115 K897130 000
00850015110443 K897130 000
00850015110436 K897130 000

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