ProFil Flow 163B03

GUDID 07290012207914

Dental Composite Restorative

SILMET LTD

Dental composite resin

• Primary Device ID: 07290012207914
• NIH Device Record Key: 7ecebe51-e177-4d4d-be5f-c37960377db8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProFil Flow
• Version Model Number: 163B03
• Catalog Number: 163B03
• 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	07290012207914 [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: 2019-01-08
• Device Publish Date: 2016-11-21

On-Brand Devices [ProFil Flow]

• 07290016787740: Dental Composite
• 07290016787566: Dental Composite Restorative
• 07290016787559: Dental Composite Restorative
• 07290016787542: Dental Composite Restorative
• 07290016787535: Dental Composite Restorative
• 07290016787528: Dental Composite Restorative
• 07290016787511: Dental Composite Restorative
• 07290016787504: Dental Composite Restorative
• 07290016787498: Dental Composite Restorative
• 07290015358033: Dental Composite Restorative
• 07290015358026: Dental Composite Restorative
• 07290015358019: Dental Composite Restorative
• 07290015358002: Dental Composite Restorative
• 07290012207990: Dental Composite Restorative
• 07290012207983: Dental Restorative Composite
• 07290012207976: Dental Composite Restorative
• 07290012207969: Dental Composite Restorative
• 07290012207952: Dental Composite Restorative
• 07290012207945: Dental Composite Restorative
• 07290012207938: Dental Composite Restorative
• 07290012207921: Dental Composite Restorative
• 07290012207914: Dental Composite Restorative
• 07290012207907: Dental Composite Restorative
• 07290012207891: Dental Composite Restorative
• 07290012207884: Dental Composite Restorative
• 07290012207877: Dental Composite Restorative
• 07290012207860: Dental Composite Restorative
• 07290012207853: Dental Composite Restorative
• 07290012207846: Dental Composite Restorative
• 07290012207839: Dental Composite Restorative
• 07290012207822: Dental Composite Restorative
• 07290012207815: Dental Composite Restorative
• 07290012207808: Dental Composite Restorative
• 07290012207792: Dental Composite Restorative
• 07290012207785: Dental Composite Restorative