BEAUTIFIL TIPS 1387

GUDID E23513870

INC BEAUTIFIL REFILL TIPS (20)

SHOFU DENTAL CORPORATION

Dental composite resin

• Primary Device ID: E23513870
• NIH Device Record Key: 1630bfe3-2ba4-41b5-93fa-b6590eb293a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BEAUTIFIL TIPS
• Version Model Number: 1387
• Catalog Number: 1387
• 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	E23513870 [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

On-Brand Devices [BEAUTIFIL TIPS]

• E23513890: A30 BEAUTIFIL REFILL TIPS (20)
• E23513880: BW BEAUTIFIL REFILL TIPS (20)
• E23513870: INC BEAUTIFIL REFILL TIPS (20)
• 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)
• E23513690: BEAUTIFIL TIPS INTRO KIT