Universal Opaque 2083

GUDID E23520830

Universal Opaque A3.50

SHOFU DENTAL CORPORATION

Dental prosthesis veneer resin

• Primary Device ID: E23520830
• NIH Device Record Key: 0e142fb7-fc0d-447a-af54-a80d788d52c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Universal Opaque
• Version Model Number: 2083
• Catalog Number: 2083
• 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 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E23520830 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131504

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: 4
• Public Version Date: 2018-07-24
• Device Publish Date: 2016-09-23

On-Brand Devices [Universal Opaque]

• E23521110: Universal Opaque Pre-Opaque
• E23521100: Universal Opaque P0
• E23521090: Universal Opaque VR0
• E23521080: Universal Opaque VP0
• E23521070: Universal Opaque IN0
• E23521060: Universal Opaque MO
• E23521050: Universal Opaque G0
• E23521040: Universal Opaque BG0
• E23521030: Universal Opaque GUM0
• E23521020: Universal Opaque W30
• E23521010: Universal Opaque W20
• E23521000: Universal Opaque WO
• E23520990: Universal Opaque R3.50
• E23520980: Universal Opaque R30
• E23520970: Universal Opaque R20
• E23520960: Universal Opaque ROOTAO
• E23520950: Universal Opaque D40
• E23520940: Universal Opaque D30
• E23520930: Universal Opaque D20
• E23520920: Universal Opaque C40
• E23520910: Universal Opaque C30
• E23520900: Universal Opaque C20
• E23520890: Universal Opaque C10
• E23520880: Universal Opaque B40
• E23520870: Universal Opaque B30
• E23520860: Universal Opaque B20
• E23520850: Universal Opaque B10
• E23520840: Universal Opaque A40
• E23520830: Universal Opaque A3.50
• E23520820: Universal Opaque A30
• E23520810: Universal Opaque A20
• E23520800: Universal Opaque A10