VINTAGE GUMMY SHADE GUIDE 9622

GUDID E23596220

Dental Shade Guide

SHOFU DENTAL CORPORATION

Dental shade guide

• Primary Device ID: E23596220
• NIH Device Record Key: 0e6865c3-c5f2-404f-ae37-0d8e5ca4d23f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VINTAGE GUMMY SHADE GUIDE
• Version Model Number: 9622
• Catalog Number: 9622
• Company DUNS: 054618202
• Company Name: SHOFU DENTAL CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E23596220 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093559

FDA Product Code

• EIH: Powder, Porcelain

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-01
• Device Publish Date: 2025-07-24

Devices Manufactured by SHOFU DENTAL CORPORATION

• E235D18A1ML0 - DENTADISC: 2026-02-02 DentaDisc CAD/CAM DISC. 98.5X18mm A1. ML
• E235D18A1MN0 - DENTADISC: 2026-02-02 DentaDisc CAD/CAM DISC. 98.5X18mm A1. MN
• E235D18A2ML0 - DENTADISC: 2026-02-02 PORTUX CAD/CAM DISC. 98.5X18mm A2. ML
• E235D18A2MN0 - DENTADISC: 2026-02-02 DentaDisc CAD/CAM DISC. 98.5X18mm A2. MN
• E235D18A35MN0 - DENTADISC: 2026-02-02 PORTUX CAD/CAM DISC. 98.5 x18mm A3.5. MN
• E235D18A3ML0 - DENTADISC: 2026-02-02 PORTUX CAD/CAM DISC. 98.5X18mm A3. ML
• E235D18A3MN0 - DENTADISC: 2026-02-02 DentaDisc CAD/CAM DISC. 98.5 x18mm A3. MN
• E235D18B1ML0 - DENTADISC: 2026-02-02 PORTUX CAD/CAM DISC. 98.5X18mm B1. ML