ProGlass Two 172002-C2

GUDID 07290016787016

Dental Glass Ionomer Cement

SILMET LTD

Glass ionomer dental cement

• Primary Device ID: 07290016787016
• NIH Device Record Key: 7c1d7af2-fc2c-49aa-8deb-a6ce269db58a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProGlass Two
• Version Model Number: 172002-C2
• Catalog Number: 172002-C2
• 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	07290016787016 [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: 2018-11-29
• Device Publish Date: 2016-11-28

On-Brand Devices [ProGlass Two]

• 07290016787221: Dental Glass Ionomer Cement
• 07290016787214: Dental Glass Ionomer Cement
• 07290016787207: Dental Glass Ionomer Cement
• 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