SciPharm Glasion Glass IonomerCement 51-025

GUDID D801SP51025B1

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. Protective Varnish Bottle. Boxed.

SCIENTIFIC PHARMACEUTICALS, INC.

Glass ionomer dental cement
Primary Device IDD801SP51025B1
NIH Device Record Key6162b1ba-0309-40e9-b738-12674900e0f2
Commercial Distribution StatusIn Commercial Distribution
Brand NameSciPharm Glasion Glass IonomerCement
Version Model NumberSP 51-025 B
Catalog Number51-025
Company DUNS096010525
Company NameSCIENTIFIC PHARMACEUTICALS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-634-3047
EmailDenise@scipharm.com
Phone800-634-3047
EmailDenise@scipharm.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD801SP51025B1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EMACement, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-03

On-Brand Devices [SciPharm Glasion Glass IonomerCement]

D801SP510421Glass Ionomer Restorative, Liner, and Cement whose application includes selected Class V restora
D801SP510411Glass Ionomer Restorative, Liner, and Cement whose application includes selected Class V restora
D801SP510311Glass Ionomer Restorative, Liner, and Cement whose application includes selected Class V restora
D801SP51031Glass Ionomer Restorative, Liner, and Cement whose application includes selected Class V restora
D801SP51025N1Glass Ionomer Restorative, Liner, and Cement whose application includes selected Class V restora
D801SP51025B1Glass Ionomer Restorative, Liner, and Cement whose application includes selected Class V restora
D801SP51022B1Glass Ionomer Restorative, Liner, and Cement whose application includes selected Class V restora
D801SP510221Glass Ionomer Restorative, Liner, and Cement whose application includes selected Class V restora
D801SP51021B1Glass Ionomer Restorative, Liner, and Cement whose application includes selected Class V restora
D801SP510211Glass Ionomer Restorative, Liner, and Cement whose application includes selected Class V restora
D801SP500311Glass Ionomer Restorative, Liner and Cement
D801SP50021Glass Ionomer Restorative, Liner, and Cement

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