AUROFLUID 2

Alloy, Gold-based 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 Aurofluid 2.

Pre-market Notification Details

Device IDK911538
510k NumberK911538
Device Name:AUROFLUID 2
ClassificationAlloy, Gold-based 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 CodeEJT  
CFR Regulation Number872.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-04-01
Decision Date1991-04-29

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