CAVIOS CAVITY LINER

Liner, Cavity, Calcium Hydroxide

NEO DENTAL CHEMICAL PRODUCTS CO., LTD.

The following data is part of a premarket notification filed by Neo Dental Chemical Products Co., Ltd. with the FDA for Cavios Cavity Liner.

Pre-market Notification Details

Device IDK111668
510k NumberK111668
Device Name:CAVIOS CAVITY LINER
ClassificationLiner, Cavity, Calcium Hydroxide
Applicant NEO DENTAL CHEMICAL PRODUCTS CO., LTD. 611 WEST 5TH STREET Austin,  TX  78701
ContactRobert Seiple
CorrespondentRobert Seiple
NEO DENTAL CHEMICAL PRODUCTS CO., LTD. 611 WEST 5TH STREET Austin,  TX  78701
Product CodeEJK  
CFR Regulation Number872.3250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-06-14
Decision Date2011-08-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04560128312561 K111668 000

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