SYSTEMP.LINK

Cement, Dental

IVOCLAR VIVADENT, INC.

The following data is part of a premarket notification filed by Ivoclar Vivadent, Inc. with the FDA for Systemp.link.

Pre-market Notification Details

Device IDK042846
510k NumberK042846
Device Name:SYSTEMP.LINK
ClassificationCement, Dental
Applicant IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. Amherst,  NY  14228
ContactDonna M Hartnett
CorrespondentDonna M Hartnett
IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. Amherst,  NY  14228
Product CodeEMA  
CFR Regulation Number872.3275 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-10-15
Decision Date2004-12-20

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