POST CEMENT (DENTAL COMPOSITE)

Cement, Dental

MEDICAL DEVICE INSPECTION CO., INC.

The following data is part of a premarket notification filed by Medical Device Inspection Co., Inc. with the FDA for Post Cement (dental Composite).

Pre-market Notification Details

Device IDK902894
510k NumberK902894
Device Name:POST CEMENT (DENTAL COMPOSITE)
ClassificationCement, Dental
Applicant MEDICAL DEVICE INSPECTION CO., INC. 55 NORTHERN BLVD. SUITE 301 Great Neck,  NY  11021
ContactAkerkar, Ph.d.
CorrespondentAkerkar, Ph.d.
MEDICAL DEVICE INSPECTION CO., INC. 55 NORTHERN BLVD. SUITE 301 Great Neck,  NY  11021
Product CodeEMA  
CFR Regulation Number872.3275 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-07-02
Decision Date1990-08-01

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