VINTAGE LD 50G BODY A2B L8612

GUDID E235L86120

VINTAGE LD 50G BODY A2B

SHOFU DENTAL CORPORATION

Dental porcelain/ceramic restoration kit
Primary Device IDE235L86120
NIH Device Record Key840c72f7-2184-4ebd-b7b9-b059c43f34a2
Commercial Distribution StatusIn Commercial Distribution
Brand NameVINTAGE LD 50G BODY A2B
Version Model NumberL8612
Catalog NumberL8612
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
HIBCCE235L86120 [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

Devices Manufactured by SHOFU DENTAL CORPORATION

04548162310439 - BEAUTIFIL II2025-12-17 BEAUTIFIL II 4.5g A1 Syringe 1pc
04548162310446 - BEAUTIFIL II2025-12-17 BEAUTIFIL II 4.5g A2 Syringe 1pc
04548162310453 - BEAUTIFIL II2025-12-17 BEAUTIFIL II 4.5g A2O Syringe 1pc
04548162310460 - BEAUTIFIL II2025-12-17 BEAUTIFIL II 4.5g A3 Syringe 1pc
04548162310477 - BEAUTIFIL II2025-12-17 BEAUTIFIL II 4.5g A3.5 Syringe 1pc
04548162310484 - BEAUTIFIL II2025-12-17 BEAUTIFIL II 4.5g A3O Syringe 1pc
04548162310491 - BEAUTIFIL II2025-12-17 BEAUTIFIL II 4.5g A4 Syringe 1pc
04548162310507 - BEAUTIFIL II2025-12-17 BEAUTIFIL II 4.5g B1 Syringe 1pc

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.