Beautifil-Bulk Restorative 2034

GUDID E23520340

BEAUTIFIL BULK REST UNIVERSAL

SHOFU DENTAL CORPORATION

Dental composite resin
Primary Device IDE23520340
NIH Device Record Keyd2f0a5b0-7e1d-4ac8-bcef-b04ed550af1c
Commercial Distribution StatusIn Commercial Distribution
Brand NameBeautifil-Bulk Restorative
Version Model Number2034
Catalog Number2034
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

Operating and Storage Conditions

Handling Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE23520340 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBFMaterial, Tooth Shade, Resin

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 Date2016-09-24

On-Brand Devices [Beautifil-Bulk Restorative]

E23520350BEAUTIFIL BULK REST A
E23520340BEAUTIFIL BULK REST UNIVERSAL
E23520330BEAUTIFIL BULK REST A TIPS
E23520320BEAUTIFIL BULK REST UNIV. TIPS

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