RESICEM

Cement, Dental

SHOFU DENTAL CORP.

The following data is part of a premarket notification filed by Shofu Dental Corp. with the FDA for Resicem.

Pre-market Notification Details

Device IDK080517
510k NumberK080517
Device Name:RESICEM
ClassificationCement, Dental
Applicant SHOFU DENTAL CORP. 1225 STONE DR. San Marcos,  CA  92078
ContactDavid P Morais
CorrespondentDavid P Morais
SHOFU DENTAL CORP. 1225 STONE DR. San Marcos,  CA  92078
Product CodeEMA  
CFR Regulation Number872.3275 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-02-25
Decision Date2008-06-11

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
E23532340 K080517 000
E23532320 K080517 000
E23532280 K080517 000
E23532270 K080517 000
E23532210 K080517 000
E23532200 K080517 000

Trademark Results [RESICEM]

Mark Image

Registration | Serial
Company
Trademark
Application Date
RESICEM
RESICEM
77575783 3618927 Live/Registered
Shofu, Inc.
2008-09-22

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