Beautifil II LS Y2281

GUDID E235Y22810

BEAUTIFIL II LS A3O

SHOFU DENTAL CORPORATION

Dental composite resin

• Primary Device ID: E235Y22810
• NIH Device Record Key: 4a6d33d4-e7c9-40da-8f0e-fc8cefb782e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Beautifil II LS
• Version Model Number: Y2281
• Catalog Number: Y2281
• 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: 760-566-3528
• Email: ckaemmerlen@shofu.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E235Y22810 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160596

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: 2018-09-28
• Device Publish Date: 2018-08-28

On-Brand Devices [Beautifil II LS]

• E235BIILSK30: BEAUTIFIL II A2 LS SAMPLE. Contains DI: E235Y22850
• E235Y22970: BEAUTIFIL II LS TIPS BW
• E235Y22960: BEAUTIFIL II LS TIPS INC
• E235Y22950: BEAUTIFIL II LS TIPS A3O
• E235Y22940: BEAUTIFIL II LS TIPS A2O
• E235Y22930: BEAUTIFIL II LS TIPS C3
• E235Y22920: BEAUTIFIL II LS TIPS C2
• E235Y22910: BEAUTIFIL II LS TIPS B3
• E235Y22900: BEAUTIFIL II LS TIPS B2
• E235Y22890: BEAUTIFIL II LS TIPS B1
• E235Y22880: BEAUTIFIL II LS TIPS A4
• E235Y22870: BEAUTIFIL II LS TIPS A3.5
• E235Y22860: BEAUTIFIL II LS TIPS A3
• E235Y22850: BEAUTIFIL II LS TIPS A2
• E235Y22840: BEAUTIFIL II LS TIPS A1
• E235Y22830: BEAUTIFIL II LS BW
• E235Y22820: BEAUTIFIL II LS INC
• E235Y22810: BEAUTIFIL II LS A3O
• E235Y22800: BEAUTIFIL II LS A2O
• E235Y22790: BEAUTIFIL II LS C3
• E235Y22780: BEAUTIFIL II LS C2
• E235Y22770: BEAUTIFIL II LS B3
• E235Y22760: BEAUTIFIL II LS B2
• E235Y22750: BEAUTIFIL II LS B1
• E235Y22740: BEAUTIFIL II LS A4
• E235Y22730: BEAUTIFIL II LS A3.5
• E235Y22720: BEAUTIFIL II LS A3
• E235Y22710: BEAUTIFIL II LS A2
• E235Y22700: BEAUTIFIL II LS A1
• E235BIILSK50: BEAUTIFIL II LS, A3, BULK KIT
• E235BIILSK5: Beautifil II LS Refill Tips Shade A3 Super Bulk Kit. Contains DI: E235Y22860
• E235BIILSK40: BEAUTIFIL II LS, A1 BULK KIT
• E235BIILSK4: Beautifil II LS Refill Tips Shade A1 Super Bulk Kit. Contains DI: E235Y22840
• E235BIILSK20: BEAUTIFIL II LS SUPER BULK KIT
• E235BIILSK2: Beautifil II LS Refill Tips Shade A2 Super Bulk Kit. Contains DI: E235Y22850
• E235BIILSK10: BEAUTIFIL II LS INTRO KIT