ECLIPTOMER

Agent, Tooth Bonding, Resin

BISCO, INC.

The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for Ecliptomer.

Pre-market Notification Details

Device IDK945604
510k NumberK945604
Device Name:ECLIPTOMER
ClassificationAgent, Tooth Bonding, Resin
Applicant BISCO, INC. 1500 W. THORNDALE AVE. Itasca,  IL  60143
ContactJames L Sandrik
CorrespondentJames L Sandrik
BISCO, INC. 1500 W. THORNDALE AVE. Itasca,  IL  60143
Product CodeKLE  
CFR Regulation Number872.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-11-15
Decision Date1995-01-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
D8281330225 K945604 000
D867CLABP0 K945604 000

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