VINTAGE MP PRESS OVER

Powder, Porcelain

SHOFU DENTAL CORPORATION

The following data is part of a premarket notification filed by Shofu Dental Corporation with the FDA for Vintage Mp Press Over.

Pre-market Notification Details

Device IDK122614
510k NumberK122614
Device Name:VINTAGE MP PRESS OVER
ClassificationPowder, Porcelain
Applicant SHOFU DENTAL CORPORATION 1225 STONE DRIVE San Marcos,  CA  92078
ContactDavid P Morais
CorrespondentDavid P Morais
SHOFU DENTAL CORPORATION 1225 STONE DRIVE San Marcos,  CA  92078
Product CodeEIH  
CFR Regulation Number872.6660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-08-27
Decision Date2013-05-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
E23596620 K122614 000
E23596430 K122614 000
E23596440 K122614 000
E23596450 K122614 000
E23596460 K122614 000
E23596470 K122614 000
E23596490 K122614 000
E23596500 K122614 000
E23596510 K122614 000
E23596530 K122614 000
E23596540 K122614 000
E23596570 K122614 000
E23596590 K122614 000
E23596410 K122614 000

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