CoreShade 1116

GUDID E23511160

CORESHADE BASE CMT PWD

SHOFU DENTAL CORPORATION

Glass ionomer dental cement

• Primary Device ID: E23511160
• NIH Device Record Key: 8aa5b8d9-9f09-4024-b7df-a7fc551f64b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CoreShade
• Version Model Number: 1116
• Catalog Number: 1116
• 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	E23511160 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K861005

FDA Product Code

• EMA: Cement, Dental

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 [CoreShade]

• E23511170: CORESHADE BASE CMT LIQ
• E23511160: CORESHADE BASE CMT PWD
• E23511150: CORESHADE BASE CMT KIT