EXTRUDE MODIFIED

Material, Impression

SYBRON DENTAL SPECIALTIES, INC.

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

Pre-market Notification Details

Device IDK012405
510k NumberK012405
Device Name:EXTRUDE MODIFIED
ClassificationMaterial, Impression
Applicant SYBRON DENTAL SPECIALTIES, INC. 1717 WEST COLLINS AVE. Orange,  CA  92667
ContactColleen Boswell
CorrespondentColleen Boswell
SYBRON DENTAL SPECIALTIES, INC. 1717 WEST COLLINS AVE. Orange,  CA  92667
Product CodeELW  
CFR Regulation Number872.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-07-30
Decision Date2001-09-04
Summary:summary

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