Beautifil Flow 1434

GUDID E23514340

BEAUTIFIL FLOW 2g A3.5 LOW FLOW

SHOFU DENTAL CORPORATION

Dental composite resin
Primary Device IDE23514340
NIH Device Record Key4496459b-a28f-4a31-80df-57b86a4d4ed9
Commercial Distribution StatusIn Commercial Distribution
Brand NameBeautifil Flow
Version Model Number1434
Catalog Number1434
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

Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE23514340 [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 Flow]

E23514820BEAUTIFIL FLOW 2g T HIGH FLOW
E23514790BEAUTIFIL FLOW 2g A3O HIGH FLOW
E23514650BEAUTIFIL FLOW 2g A4 HIGH FLOW
E23514640BEAUTIFIL FLOW 2g A3.5 HIGH FL
E23514630BEAUTIFIL FLOW 2g A3 HIGH FLOW
E23514620BEAUTIFIL FLOW 2g A2 HIGH FLOW
E23514610BEAUTIFIL FLOW 2g A1 HIGH FLOW
E23514510BEAUTIFIL FLOW 2g G LOW FLOW
E23514490BEAUTIFIL FLOW 2g A3O LOW FLOW
E23514350BEAUTIFIL FLOW 2g A4 LOW FLOW
E23514340BEAUTIFIL FLOW 2g A3.5 LOW FLOW
E23514330BEAUTIFIL FLOW 2g A3 LOW FLOW
E23514320BEAUTIFIL FLOW 2g A2 LOW FLOW
E23514310BEAUTIFIL FLOW 2g A1 LOW FLOW

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