ProFil 184A35-P

GUDID 07290015358309

Dental Composite Restorative

SILMET LTD

Dental composite resin

• Primary Device ID: 07290015358309
• NIH Device Record Key: 34acb4e5-559e-41de-8ee1-77fca1d3d5f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProFil
• Version Model Number: 184A35-P
• Catalog Number: 184A35-P
• 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	07290015358309 [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: 2016-11-21

On-Brand Devices [ProFil]

• 07290016787726: Dental Composite
• 07290016787719: Dental Composite
• 07290016787702: Dental Composite
• 07290016787696: Dental Composite
• 07290016787689: Dental Composite
• 07290016787672: Dental Composite
• 07290016787665: Dental Composite
• 07290016787641: Dental Composite material
• 07290015358743: Dental Composite Restorative
• 07290015358736: Dental Composite Restorative
• 07290015358729: Dental Composite Restorative
• 07290015358712: Dental Composite Restorative
• 07290015358705: Dental Composite Restorative
• 07290015358699: Dental Composite Restorative
• 07290015358682: Dental Composite Restorative
• 07290015358675: Dental Composite Restorative
• 07290015358668: Dental Composite Restorative
• 07290015358651: Dental Composite Restorative
• 07290015358644: Dental Composite Restorative
• 07290015358637: Dental Composite Restorative
• 07290015358620: Dental Composite Restorative
• 07290015358613: Dental Composite Restorative
• 07290015358606: Dental Composite Restorative
• 07290015358590: Dental Composite Restorative
• 07290015358583: Dental Composite Restorative
• 07290015358576: Dental Composite Restorative
• 07290015358569: Dental Composite Restorative
• 07290015358552: Dental Composite Restorative
• 07290015358545: Dental Composite Restorative
• 07290015358538: Dental Composite Restorative
• 07290015358521: Dental Composite Restorative
• 07290015358514: Dental Composite Restorative
• 07290015358507: Dental Composite Restorative
• 07290015358491: Dental Composite Restorative
• 07290015358484: Dental Composite Restorative
• 07290015358477: Dental Composite Restorative
• 07290015358460: Dental Composite Restorative
• 07290015358453: Dental Composite Restorative
• 07290015358446: Dental Composite Restorative
• 07290015358439: Dental Composite Restorative
• 07290015358422: Dental Composite Restorative
• 07290015358408: Dental Composite Restorative
• 07290015358392: Dental Composite Restorative
• 07290015358385: Dental Composite Restorative
• 07290015358378: Dental Composite Restorative
• 07290015358361: Dental Composite Restorative
• 07290015358354: Dental Composite Restorative
• 07290015358347: Dental Composite Restorative
• 07290015358330: Dental Composite Restorative
• 07290015358323: Dental Composite Restorative