ProGlass One 171002

GUDID 07290015358897

Dental Glass Ionomer Cement

SILMET LTD

Glass ionomer dental cement

• Primary Device ID: 07290015358897
• NIH Device Record Key: aec3ba2a-bc75-4461-98da-599b7f2b0e86
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProGlass One
• Version Model Number: 171002
• Catalog Number: 171002
• 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	07290015358897 [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: 2016-11-28

On-Brand Devices [ProGlass One]

• 07290016787184: Dental Glass Ionomer Cement
• 07290015358897: Dental Glass Ionomer Cement
• 07290015358880: Dental Glass Ionomer Cements