ProFil Flow 160008

GUDID 07290015358019

Dental Composite Restorative

SILMET LTD

Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin

• Primary Device ID: 07290015358019
• NIH Device Record Key: 00c5a4cc-a3f2-431d-964e-e52df7b81618
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProFil Flow
• Version Model Number: 160008
• Catalog Number: 160008
• 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	07290015358019 [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: 2016-10-26

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