BEAUTIFIL TIPS 1371

GUDID E23513710

A1 BEAUTIFIL REFILL TIPS (20)

SHOFU DENTAL CORPORATION

Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin

• Primary Device ID: E23513710
• NIH Device Record Key: d7bb006b-6f96-4f39-be05-e2413b87b3de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BEAUTIFIL TIPS
• Version Model Number: 1371
• Catalog Number: 1371
• 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	E23513710 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010914

FDA Product Code

• EBF: MATERIAL, TOOTH SHADE, RESIN

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

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• E23513880: BW BEAUTIFIL REFILL TIPS (20)
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• E23513840: C3 BEAUTIFIL REFILL TIPS (20)
• E23513830: C2 BEAUTIFIL REFILL TIPS (20)
• E23513790: B3 BEAUTIFIL REFILL TIPS (20)
• E23513780: B2 BEAUTIFIL REFILL TIPS (20)
• E23513770: B1 BEAUTIFIL REFILL TIPS (20)
• E23513750: A4 BEAUTIFIL REFILL TIPS (20)
• E23513740: A3.5 BEAUTIFIL REFILL TIPS(20)
• E23513730: A3 BEAUTIFIL REFILL TIPS (20)
• E23513720: A2 BEAUTIFIL REFILL TIPS (20)
• E23513710: A1 BEAUTIFIL REFILL TIPS (20)
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