ProGlass Two 172001-A3

GUDID 07290015358927

Dental Glass Ionomer Cement

SILMET LTD

Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement

• Primary Device ID: 07290015358927
• NIH Device Record Key: f4af629e-22c5-4ef5-b093-9cd503796603
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProGlass Two
• Version Model Number: 172001-A3
• Catalog Number: 172001-A3
• 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	07290015358927 [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 Two]

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• 07290016787191: Dental Glass Ionomer Cement
• 07290016787016: Dental Glass Ionomer Cement
• 07290016787009: Dental Glass Ionomer Cement
• 07290015358996: Dental Glass Ionomer Cement
• 07290015358989: Dental Glass Ionomer Cement
• 07290015358972: Dental Glass Ionomer Cement
• 07290015358965: Dental Glass Ionomer Cement
• 07290015358958: Dental Glass Ionomer Cement
• 07290015358941: Dental Glass Ionomer Cement
• 07290015358934: Dental Glass Ionomer Cement
• 07290015358927: Dental Glass Ionomer Cement
• 07290015358910: Dental Glass Ionomer Cement
• 07290015358903: Dental Glass Ionomer Cement