BEAUTIFIL II GINGIVA Y2257

GUDID E235Y22570

BEAUTIFIL II GINGIVA G-DP 2.5G

SHOFU DENTAL CORPORATION

Dental composite resin

• Primary Device ID: E235Y22570
• NIH Device Record Key: 20c7eb60-748a-41da-9c0a-bcfacdc2aaa7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BEAUTIFIL II GINGIVA
• Version Model Number: Y2257
• Catalog Number: Y2257
• 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	E235Y22570 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151700

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 II GINGIVA]

• E235Y22600: BEAUTIFIL II GINGIVA G-OR 2.5G
• E235Y22590: BEAUTIFIL II GINGIVA G-BR 2.5G
• E235Y22580: BEAUTIFIL II GINGIVA G-V 2.5G
• E235Y22570: BEAUTIFIL II GINGIVA G-DP 2.5G
• E235Y22560: BEAUTIFIL II GINGIVA G-LP 2.5G