VINTAGE PRO ENAM EFFECT T-GLAS P0343

GUDID E235P03430

VINTAGE PRO ENAM EFFECT T-GLAS

SHOFU DENTAL CORPORATION

Dental porcelain/ceramic restoration kit
Primary Device IDE235P03430
NIH Device Record Key0eb72243-99c5-45ef-a5e9-d84118359b35
Commercial Distribution StatusIn Commercial Distribution
Brand NameVINTAGE PRO ENAM EFFECT T-GLAS
Version Model NumberP0343
Catalog NumberP0343
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

Phone+1(800)827-5262
Emailcustomer-service@shofu.com
Phone+1(800)827-5262
Emailcustomer-service@shofu.com
Phone+1(800)827-5262
Emailcustomer-service@shofu.com
Phone+1(800)827-5262
Emailcustomer-service@shofu.com
Phone+1(800)827-5262
Emailcustomer-service@shofu.com
Phone+1(800)827-5262
Emailcustomer-service@shofu.com
Phone+1(800)827-5262
Emailcustomer-service@shofu.com
Phone+1(800)827-5262
Emailcustomer-service@shofu.com
Phone+1(800)827-5262
Emailcustomer-service@shofu.com
Phone+1(800)827-5262
Emailcustomer-service@shofu.com
Phone+1(800)827-5262
Emailcustomer-service@shofu.com
Phone+1(800)827-5262
Emailcustomer-service@shofu.com
Phone+1(800)827-5262
Emailcustomer-service@shofu.com
Phone+1(800)827-5262
Emailcustomer-service@shofu.com
Phone+1(800)827-5262
Emailcustomer-service@shofu.com
Phone+1(800)827-5262
Emailcustomer-service@shofu.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE235P03430 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EIHPOWDER, PORCELAIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-11
Device Publish Date2021-02-03

On-Brand Devices [VINTAGE PRO ENAM EFFECT T-GLAS]

E235P03630VINTAGE PRO ENAM EFFECT T-GLAS
E235P03430VINTAGE PRO ENAM EFFECT T-GLAS

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