BEAUTIFIL II Enamel Y2253

GUDID 04548162311429

BEAUTIFIL II Enamel 2.5g AM Syringe 1pc

SHOFU DENTAL CORPORATION

Dental composite resin

• Primary Device ID: 04548162311429
• NIH Device Record Key: 0a252b6c-f2b5-4705-a6d4-cdb664c22f91
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BEAUTIFIL II Enamel
• Version Model Number: Y2253
• Catalog Number: Y2253
• 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: true
• 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(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04548162311429 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151699

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: 2025-12-17
• Device Publish Date: 2025-12-09

On-Brand Devices [BEAUTIFIL II Enamel]

• E235Y22530: BEAUTIFIL II ENAMEL AM 2.5G
• E235Y22520: BEAUTIFIL II ENAMEL LVT 2.5G
• E235Y22510: BEAUTIFIL II ENAMEL HVT 2.5G
• E235Y22500: BEAUTIFIL II ENAMEL T 2.5G
• 04548162311450: BEAUTIFIL II Enamel 2.5g T Syringe 1pc
• 04548162311443: BEAUTIFIL II Enamel 2.5g LVT Syringe 1pc
• 04548162311436: BEAUTIFIL II Enamel 2.5g HVT Syringe 1pc
• 04548162311429: BEAUTIFIL II Enamel 2.5g AM Syringe 1pc