VINTAGE PRO UNI-LAYER HT 15G P0441

GUDID E235P04410

VINTAGE PRO UNI-LAYER HT 15G

SHOFU DENTAL CORPORATION

Dental porcelain/ceramic restoration kit

• Primary Device ID: E235P04410
• NIH Device Record Key: a07bb185-60e8-4520-a25a-b11e1ef32fb1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VINTAGE PRO UNI-LAYER HT 15G
• Version Model Number: P0441
• Catalog Number: P0441
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E235P04410 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181496

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: 2021-02-11
• Device Publish Date: 2021-02-03

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