Dental - Joy

GUDID 00817169020721

JOYFIL Nano-Hybrid Composite 4.5gm Refill Syringe B1

3D DENTAL DESIGNS AND DEVELOPMENT, LLC

Dental composite resin

• Primary Device ID: 00817169020721
• NIH Device Record Key: 540df591-8724-419d-9976-3dfab2b02a89
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dental - Joy
• Version Model Number: JFN-SB1
• Company DUNS: 080194935
• Company Name: 3D DENTAL DESIGNS AND DEVELOPMENT, LLC
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 38 Degrees Fahrenheit and 76 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817169020721 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K994224

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: 2019-09-27
• Device Publish Date: 2016-12-14

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