SONICFILL 2010

Material, Tooth Shade, Resin

SYBRON DENTAL SPECIALTIES, INC.

The following data is part of a premarket notification filed by Sybron Dental Specialties, Inc. with the FDA for Sonicfill 2010.

Pre-market Notification Details

Device IDK091091
510k NumberK091091
Device Name:SONICFILL 2010
ClassificationMaterial, Tooth Shade, Resin
Applicant SYBRON DENTAL SPECIALTIES, INC. 1717 W. COLLINS AVE. Orange,  CA  92867
ContactClaudia Ortiz
CorrespondentClaudia Ortiz
SYBRON DENTAL SPECIALTIES, INC. 1717 W. COLLINS AVE. Orange,  CA  92867
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-04-16
Decision Date2009-10-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
EKAV100720000 K091091 000

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