ProFil Temp 19T4X7

GUDID 07290015358828

Dental Composite Restorative

SILMET LTD

Dental composite resin

• Primary Device ID: 07290015358828
• NIH Device Record Key: 4ccc92e2-eb6a-45c9-8303-be6fe8c2622e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProFil Temp
• Version Model Number: 19T4X7
• Catalog Number: 19T4X7
• Company DUNS: 600071344
• Company Name: SILMET 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: false
• Expiration Date: true
• 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	07290015358828 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103190

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: 2018-12-28
• Device Publish Date: 2016-10-13

On-Brand Devices [ProFil Temp]

• 07290015358828: Dental Composite Restorative
• 07290015358811: Dental Composite Restorative