CERAPALL 6 -- MODIFIED

Alloy, Other Noble Metal

METALOR DENTAL USA CORP.

The following data is part of a premarket notification filed by Metalor Dental Usa Corp. with the FDA for Cerapall 6 -- Modified.

Pre-market Notification Details

Device IDK924292
510k NumberK924292
Device Name:CERAPALL 6 -- MODIFIED
ClassificationAlloy, Other Noble Metal
Applicant METALOR DENTAL USA CORP. 457 LAUREL RD. BOX 369 Rockville Centre,  NY  11571 -0369
ContactBrian F Schiller
CorrespondentBrian F Schiller
METALOR DENTAL USA CORP. 457 LAUREL RD. BOX 369 Rockville Centre,  NY  11571 -0369
Product CodeEJS  
CFR Regulation Number872.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-06-29
Decision Date1993-03-01

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