BeautiSealant 1798

GUDID E23517980

BEAUTISEALANT SET

SHOFU DENTAL CORPORATION

Dental unfilled resin sealant/coating
Primary Device IDE23517980
NIH Device Record Keydbf578b4-6080-4cb7-b458-1b85a34670a5
Commercial Distribution StatusIn Commercial Distribution
Brand NameBeautiSealant
Version Model Number1798
Catalog Number1798
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
HIBCCE23517980 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBCSealant, Pit And Fissure, And Conditioner

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-08-09
Device Publish Date2016-09-26

On-Brand Devices [BeautiSealant]

E23518000BEAUTISEALANT PRIMER
E23517990BEAUTISEALANT PASTE 1.2g
E23517980BEAUTISEALANT SET
E23517940BEAUTISEALANT NEEDLE TIPS

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