CUTTERSIL ACTIVATOR UNIVERSAL PLUS

Material, Impression

HERAEUS KULZER GMBH

The following data is part of a premarket notification filed by Heraeus Kulzer Gmbh with the FDA for Cuttersil Activator Universal Plus.

Pre-market Notification Details

Device IDK080338
510k NumberK080338
Device Name:CUTTERSIL ACTIVATOR UNIVERSAL PLUS
ClassificationMaterial, Impression
Applicant HERAEUS KULZER GMBH 4315 SOUTH LAFAYETTE BLVD. South Bend,  IN  46614 -2517
ContactCheryl V Zimmerman
CorrespondentCheryl V Zimmerman
HERAEUS KULZER GMBH 4315 SOUTH LAFAYETTE BLVD. South Bend,  IN  46614 -2517
Product CodeELW  
CFR Regulation Number872.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-02-07
Decision Date2008-04-21
Summary:summary

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