ProBase 170005

GUDID 07290016787313

Dental Glass Ionomer Cement

SILMET LTD

Glass ionomer dental cement

• Primary Device ID: 07290016787313
• NIH Device Record Key: 5262a84c-3c32-46c6-bfd9-c1a19d7f8ee9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProBase
• Version Model Number: 170005
• Catalog Number: 170005
• 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	07290016787313 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101869

FDA Product Code

• EMA: Cement, Dental

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: 2018-12-03
• Device Publish Date: 2016-12-15

On-Brand Devices [ProBase]

• 07290016787313: Dental Glass Ionomer Cement
• 07290016787306: Dental Glass Ionomer Cement
• 07290015358873: Dental Glass Ionomer Cement
• 07290015358866: Dental Glass Ionomer Cement