VINTAGE PRO COLOR EFFECT BR 50 P0429

GUDID E235P04290

VINTAGE PRO COLOR EFFECT BR 50

SHOFU DENTAL CORPORATION

Dental porcelain/ceramic restoration kit

• Primary Device ID: E235P04290
• NIH Device Record Key: dc4aab16-0c30-4af8-81b6-6058a70ce5ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VINTAGE PRO COLOR EFFECT BR 50
• Version Model Number: P0429
• Catalog Number: P0429
• 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	E235P04290 [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

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• E235Y23510 - Beautifil Flow Plus X: 2024-10-15 BEAUTIFIL FLOW PLUS X APPLICATION TIPS (50 units)
• 14548162335460 - ROBOT POINTS PRO-CUT: 2024-09-12 ROBOT POINTS PRO-CUT FG D006EF 5pcs
• 14548162335477 - ROBOT POINTS PRO-CUT: 2024-09-12 ROBOT POINTS PRO-CUT FG D007EF 5pcs
• 14548162335484 - ROBOT POINTS PRO-CUT: 2024-09-12 ROBOT POINTS PRO-CUT FG D010EF 5pcs
• 14548162335491 - ROBOT POINTS PRO-CUT: 2024-09-12 ROBOT POINTS PRO-CUT FG D027EF 5pcs
• 14548162335507 - ROBOT POINTS PRO-CUT: 2024-09-12 ROBOT POINTS PRO-CUT FG D053EF 5pcs
• 14548162335514 - ROBOT POINTS PRO-CUT: 2024-09-12 ROBOT POINTS PRO-CUT FG D054EF 5pcs