BeautiCem SA 3214

GUDID E23532140

BeautiCem SA Auto-Mix Ivory

SHOFU DENTAL CORPORATION

Dental composite resin
Primary Device IDE23532140
NIH Device Record Key2e97825c-b50f-4ee8-8045-f6454549c016
Commercial Distribution StatusIn Commercial Distribution
Brand NameBeautiCem SA
Version Model Number3214
Catalog Number3214
Company DUNS054618202
Company NameSHOFU DENTAL CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone760-566-3528
Emailckaemmerlen@shofu.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE23532140 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EMACement, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

On-Brand Devices [BeautiCem SA]

E23532140BeautiCem SA Auto-Mix Ivory
E23532130BeautiCem SA Auto-Mix Clear

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