SciPharm Glasion Glass IonomerCement 51-021

GUDID D801SP510211

Glass Ionomer Restorative, Liner, and Cement whose application includes selected Class V restorations, permanent cementation of crowns and bridges, cementation of orthodontic bands, and lining of cavities. Non-Boxed

SCIENTIFIC PHARMACEUTICALS, INC.

Glass ionomer dental cement

• Primary Device ID: D801SP510211
• NIH Device Record Key: df1fdabf-4a3d-4d99-b898-21a4d47fd210
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SciPharm Glasion Glass IonomerCement
• Version Model Number: SP 51-021
• Catalog Number: 51-021
• Company DUNS: 096010525
• Company Name: SCIENTIFIC PHARMACEUTICALS, INC.
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-634-3047
• Email: Denise@scipharm.com
• Phone: 800-634-3047
• Email: Denise@scipharm.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D801SP510211 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K895386

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-03

On-Brand Devices [SciPharm Glasion Glass IonomerCement]

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• D801SP510411: Glass Ionomer Restorative, Liner, and Cement whose application includes selected Class V restora
• D801SP510311: Glass Ionomer Restorative, Liner, and Cement whose application includes selected Class V restora
• D801SP51031: Glass Ionomer Restorative, Liner, and Cement whose application includes selected Class V restora
• D801SP51025N1: Glass Ionomer Restorative, Liner, and Cement whose application includes selected Class V restora
• D801SP51025B1: Glass Ionomer Restorative, Liner, and Cement whose application includes selected Class V restora
• D801SP51022B1: Glass Ionomer Restorative, Liner, and Cement whose application includes selected Class V restora
• D801SP510221: Glass Ionomer Restorative, Liner, and Cement whose application includes selected Class V restora
• D801SP51021B1: Glass Ionomer Restorative, Liner, and Cement whose application includes selected Class V restora
• D801SP510211: Glass Ionomer Restorative, Liner, and Cement whose application includes selected Class V restora
• D801SP500311: Glass Ionomer Restorative, Liner and Cement
• D801SP50021: Glass Ionomer Restorative, Liner, and Cement