VINTAGE PRO POWD OPAQ W3O 50G P0081

GUDID E235P00810

VINTAGE PRO POWD OPAQ W3O 50G

SHOFU DENTAL CORPORATION

Dental porcelain/ceramic restoration kit

• Primary Device ID: E235P00810
• NIH Device Record Key: 0672e92a-44aa-4b67-b345-8d48200f02f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VINTAGE PRO POWD OPAQ W3O 50G
• Version Model Number: P0081
• Catalog Number: P0081
• 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	E235P00810 [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

• E235D18B1MN0 - DENTADISC: 2026-02-10 DentaDisc CAD/CAM PMMA Disc 98.5x18mm B1.MN
• E235D20A1MN0 - DENTADISC: 2026-02-10 DentaDisc CAD/CAM PMMA DISC. 98.5X20mm A1. MN
• E235D20B1MN0 - DENTADISC: 2026-02-10 DentaDisc CAD/CAM PMMA DISC 98.5x20mm B1.MN
• E235D25A1MN0 - DENTADISC: 2026-02-10 DentaDisc CAD/CAM PMMA DISC. 98.5X25mm A1. MN
• E235D25A2MN0 - DENTADISC: 2026-02-10 DentaDisc CAD/CAM PMMA DISC. 98.5x25mm A2. MN
• E235D30A1MN0 - DENTADISC: 2026-02-10 DentaDisc CAD/CAM PMMA DISC.98.5x30mm A1. MN
• E235D30A2MN0 - DENTADISC: 2026-02-10 DentaDisc CAD/CAM PMMA DISC. 98.5X30mm A2. MN
• E235D30B1MN0 - DENTADISC: 2026-02-10 DentaDisc CAD/CAM PMMA DISC. 98.5X30mm B1. MN