Beautifil II Opaquer 1364

GUDID E23513640

BEAUTIFIL OPAQUER LO

SHOFU DENTAL CORPORATION

Dental composite resin

• Primary Device ID: E23513640
• NIH Device Record Key: ef68d8ab-5de6-483d-8351-05d58a4fbaa8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Beautifil II Opaquer
• Version Model Number: 1364
• Catalog Number: 1364
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E23513640 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080068

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 II Opaquer]

• E23513640: BEAUTIFIL OPAQUER LO
• E23513630: BEAUTIFIL OPAQUER UO