DE corematrix

GUDID 06974208580005

De Corematrix Co., Ltd.

Dental porcelain/ceramic restoration kit

• Primary Device ID: 06974208580005
• NIH Device Record Key: 4b967f55-85d3-48a9-bd4b-88861dde6d6b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DE corematrix
• Version Model Number: CMC/CMW
• Company DUNS: 554479198
• Company Name: De Corematrix Co., Ltd.
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06974208580005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192262

FDA Product Code

• EIH: Powder, Porcelain

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: 2021-03-26
• Device Publish Date: 2021-03-18