HOFFMANN'S CEMENT (PHOSPHATE, NORMAL)

Cement, Dental

TEMREX CORP.

The following data is part of a premarket notification filed by Temrex Corp. with the FDA for Hoffmann's Cement (phosphate, Normal).

Pre-market Notification Details

Device IDK123273
510k NumberK123273
Device Name:HOFFMANN'S CEMENT (PHOSPHATE, NORMAL)
ClassificationCement, Dental
Applicant TEMREX CORP. 300 Buffalo Ave Freeport,  NY  11520
ContactHabib Lafir
CorrespondentHabib Lafir
TEMREX CORP. 300 Buffalo Ave Freeport,  NY  11520
Product CodeEMA  
CFR Regulation Number872.3275 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-10-19
Decision Date2012-12-07

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