Beautifil II Opaquer 1363

GUDID E23513630

BEAUTIFIL OPAQUER UO

SHOFU DENTAL CORPORATION

Dental composite resin
Primary Device IDE23513630
NIH Device Record Key7c622daa-e759-4255-80b8-43011ffc26a0
Commercial Distribution StatusIn Commercial Distribution
Brand NameBeautifil II Opaquer
Version Model Number1363
Catalog Number1363
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
HIBCCE23513630 [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 II Opaquer]

E23513640BEAUTIFIL OPAQUER LO
E23513630BEAUTIFIL OPAQUER UO

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.