VINTAGE GUMMY SHADE GUIDE 9622

GUDID E23596220

Dental Shade Guide

SHOFU DENTAL CORPORATION

Dental shade guide
Primary Device IDE23596220
NIH Device Record Key0e6865c3-c5f2-404f-ae37-0d8e5ca4d23f
Commercial Distribution StatusIn Commercial Distribution
Brand NameVINTAGE GUMMY SHADE GUIDE
Version Model Number9622
Catalog Number9622
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone760-736-3277
Emailcustomer-service@shofu.com
Phone760-736-3277
Emailcustomer-service@shofu.com
Phone760-736-3277
Emailcustomer-service@shofu.com
Phone760-736-3277
Emailcustomer-service@shofu.com
Phone760-736-3277
Emailcustomer-service@shofu.com
Phone760-736-3277
Emailcustomer-service@shofu.com
Phone760-736-3277
Emailcustomer-service@shofu.com
Phone760-736-3277
Emailcustomer-service@shofu.com
Phone760-736-3277
Emailcustomer-service@shofu.com
Phone760-736-3277
Emailcustomer-service@shofu.com
Phone760-736-3277
Emailcustomer-service@shofu.com
Phone760-736-3277
Emailcustomer-service@shofu.com
Phone760-736-3277
Emailcustomer-service@shofu.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE23596220 [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 Date2025-08-01
Device Publish Date2025-07-24

Devices Manufactured by SHOFU DENTAL CORPORATION

E235S3DCR0 - Dentaprint2025-09-03 Dentaprint 3D Cast Resin Sample
E235S3DMR0 - Dentaprint2025-09-03 Dentaprint 3D Model Resin Sample
E235S3DOR0 - Dentaprint2025-09-03 Dentaprint 3D Ortho Model Resin Sample
E235S3DSGR0 - Dentaprint2025-09-03 Dentaprint 3D Surgical Guide Resin Sample
E235S3DTIR0 - Dentaprint2025-09-03 Dentaprint 3D Try-In Resin (A1) Sample
E23596220 - VINTAGE GUMMY SHADE GUIDE2025-08-01Dental Shade Guide
E23596220 - VINTAGE GUMMY SHADE GUIDE2025-08-01 Dental Shade Guide
E235IEWK0 - INCISAL EDGE WEAR KIT2024-10-24 IEWK (INCISAL EDGE WEAR KIT) Contains: Beautibond Bulk (E23517820), One Gloss PS IC (Bulk) In Pouch (E23501780). One Gloss PS
E235Y23510 - Beautifil Flow Plus X2024-10-15 BEAUTIFIL FLOW PLUS X APPLICATION TIPS (50 units)

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