BEAUTIFIL II GINGIVA Y2258

GUDID E235Y22580

BEAUTIFIL II GINGIVA G-V 2.5G

SHOFU DENTAL CORPORATION

Dental composite resin
Primary Device IDE235Y22580
NIH Device Record Keybcf5c767-4f5c-4b61-b3f7-be585346d2e5
Commercial Distribution StatusIn Commercial Distribution
Brand NameBEAUTIFIL II GINGIVA
Version Model NumberY2258
Catalog NumberY2258
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
HIBCCE235Y22580 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-11
Device Publish Date2021-02-03

On-Brand Devices [BEAUTIFIL II GINGIVA]

E235Y22600BEAUTIFIL II GINGIVA G-OR 2.5G
E235Y22590BEAUTIFIL II GINGIVA G-BR 2.5G
E235Y22580BEAUTIFIL II GINGIVA G-V 2.5G
E235Y22570BEAUTIFIL II GINGIVA G-DP 2.5G
E235Y22560BEAUTIFIL II GINGIVA G-LP 2.5G

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