Beautifil Flow 1451

GUDID E23514510

BEAUTIFIL FLOW 2g G LOW FLOW

SHOFU DENTAL CORPORATION

Dental composite resin

• Primary Device ID: E23514510
• NIH Device Record Key: 73e3c2c5-093e-4758-9994-ac977558fea7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Beautifil Flow
• Version Model Number: 1451
• Catalog Number: 1451
• 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	E23514510 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051818

FDA Product Code

• EBF: Material, Tooth Shade, Resin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [Beautifil Flow]

• E23514820: BEAUTIFIL FLOW 2g T HIGH FLOW
• E23514790: BEAUTIFIL FLOW 2g A3O HIGH FLOW
• E23514650: BEAUTIFIL FLOW 2g A4 HIGH FLOW
• E23514640: BEAUTIFIL FLOW 2g A3.5 HIGH FL
• E23514630: BEAUTIFIL FLOW 2g A3 HIGH FLOW
• E23514620: BEAUTIFIL FLOW 2g A2 HIGH FLOW
• E23514610: BEAUTIFIL FLOW 2g A1 HIGH FLOW
• E23514510: BEAUTIFIL FLOW 2g G LOW FLOW
• E23514490: BEAUTIFIL FLOW 2g A3O LOW FLOW
• E23514350: BEAUTIFIL FLOW 2g A4 LOW FLOW
• E23514340: BEAUTIFIL FLOW 2g A3.5 LOW FLOW
• E23514330: BEAUTIFIL FLOW 2g A3 LOW FLOW
• E23514320: BEAUTIFIL FLOW 2g A2 LOW FLOW
• E23514310: BEAUTIFIL FLOW 2g A1 LOW FLOW