TRYOUT-VPS HOLDING PASTE

Cement, Dental

CROWN DELTA CORP.

The following data is part of a premarket notification filed by Crown Delta Corp. with the FDA for Tryout-vps Holding Paste.

Pre-market Notification Details

Device IDK122974
510k NumberK122974
Device Name:TRYOUT-VPS HOLDING PASTE
ClassificationCement, Dental
Applicant CROWN DELTA CORP. 1550 FRONT ST. Yorktown Heights,  NY  10598
ContactMark Konopka
CorrespondentMark Konopka
CROWN DELTA CORP. 1550 FRONT ST. Yorktown Heights,  NY  10598
Product CodeEMA  
CFR Regulation Number872.3275 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-09-26
Decision Date2013-05-17

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