FormCore DC

GUDID 10852253006219

Dental Composite Resin for Core Build-up

J. MORITA U.S.A., INC

Dental composite resin

• Primary Device ID: 10852253006219
• NIH Device Record Key: e81f0155-4a59-401f-8cd2-6a1064b055d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FormCore DC
• Version Model Number: 28700100
• Company DUNS: 021866033
• Company Name: J. MORITA U.S.A., INC
• 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: true
• Device Combination Product: false
• Single Use: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10852253006219 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061664

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: 2020-01-28
• Device Publish Date: 2016-09-22

On-Brand Devices [FormCore DC ]

• 18522530060211: Dental Composite Resin for Core Build-up
• 10852253006219: Dental Composite Resin for Core Build-up