HERACERAM ZIRKONIA

Powder, Porcelain

HERAEUS KULZER, INC.

The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Heraceram Zirkonia.

Pre-market Notification Details

Device IDK052543
510k NumberK052543
Device Name:HERACERAM ZIRKONIA
ClassificationPowder, Porcelain
Applicant HERAEUS KULZER, INC. 4315 SOUTH LAFAYETTE BLVD. South Bend,  IN  46614 -2517
ContactCheryl V Zimmerman
CorrespondentCheryl V Zimmerman
HERAEUS KULZER, INC. 4315 SOUTH LAFAYETTE BLVD. South Bend,  IN  46614 -2517
Product CodeEIH  
CFR Regulation Number872.6660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-09-15
Decision Date2005-10-25
Summary:summary

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