SEAL & BOND DIRECT BONDING ORTHODONTIC

Adhesive, Bracket And Tooth Conditioner, Resin

SCIENTIFIC PHARMACEUTICALS, INC.

The following data is part of a premarket notification filed by Scientific Pharmaceuticals, Inc. with the FDA for Seal & Bond Direct Bonding Orthodontic.

Pre-market Notification Details

Device IDK790962
510k NumberK790962
Device Name:SEAL & BOND DIRECT BONDING ORTHODONTIC
ClassificationAdhesive, Bracket And Tooth Conditioner, Resin
Applicant SCIENTIFIC PHARMACEUTICALS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDYH  
CFR Regulation Number872.3750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-05-22
Decision Date1979-07-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
D801SP600241 K790962 000
D801SP60016B1 K790962 000
D801SP60016 K790962 000

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