BEAUTIFIL II Gingiva Y2258

GUDID 04548162311504

BEAUTIFIL II Gingiva 2.5g G-V Syringe 1pc

SHOFU DENTAL CORPORATION

Dental composite resin

• Primary Device ID: 04548162311504
• NIH Device Record Key: 6558113b-9520-420c-ab01-1446318f4b3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BEAUTIFIL II Gingiva
• Version Model Number: Y2258
• Catalog Number: Y2258
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04548162311504 [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: 2025-12-17
• Device Publish Date: 2025-12-09

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
• 04548162311504: BEAUTIFIL II Gingiva 2.5g G-V Syringe 1pc
• 04548162311498: BEAUTIFIL II Gingiva 2.5g G-Or Syringe 1pc
• 04548162311481: BEAUTIFIL II Gingiva 2.5g G-LP Syringe 1pc
• 04548162311474: BEAUTIFIL II Gingiva 2.5g G-DP Syringe 1pc
• 04548162311467: BEAUTIFIL II Gingiva 2.5g G-Br Syringe 1pc