SOLARO 33

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 Solaro 33.

Pre-market Notification Details

Device IDK970045
510k NumberK970045
Device Name:SOLARO 33
ClassificationAlloy, Other Noble Metal
Applicant METALOR DENTAL USA CORP. 255 JOHN L. DIETSCH BLVD. North Attleborough,  MA  02761
ContactKenneth A Putney
CorrespondentKenneth A Putney
METALOR DENTAL USA CORP. 255 JOHN L. DIETSCH BLVD. North Attleborough,  MA  02761
Product CodeEJS  
CFR Regulation Number872.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-01-06
Decision Date1997-03-05

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