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

E2351000T0 - TRINIA2026-03-16 TRINIA DISC 98mm x 15mm Ivory
E2351000TP0 - TRINIA2026-03-16 TRINIA DISC 98mm x 15mm Pink
E2351001T0 - TRINIA2026-03-16 TRINIA DISC 98mm x 25mm Ivory
E2351001TP0 - TRINIA2026-03-16 TRINIA DISC 98mm x 25mm Pink
E2351002T0 - TRINIA2026-03-16 TRINIA BLOCK 55mm x 19mm x 15mm Ivory
E2351003T0 - TRINIA2026-03-16 TRINIA BLOCK 40mm x 19mm x 15mm Ivory
E2351004T0 - TRINIA2026-03-16 TRINIA D-SHAPE 89mm x 71mm x 15mm Ivory
E2351004TP0 - TRINIA2026-03-16 TRINIA D-SHAPE 89mm x 71mm x 15mm Pink

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.