PAGALIN 2

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 Pagalin 2.

Pre-market Notification Details

Device IDK911675
510k NumberK911675
Device Name:PAGALIN 2
ClassificationAlloy, Other Noble Metal
Applicant METALOR DENTAL USA CORP. 457 LAUREL RD. BOX 369 Rockville Centre,  NY  11571 -0369
ContactBrian Schiller
CorrespondentBrian 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 Received1991-04-11
Decision Date1991-06-27

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