Home GUDID D801SP510311 SciPharm Glasion Glass IonomerCement
Primary DI D801SP510311
Brand SciPharm Glasion Glass IonomerCement
Company SCIENTIFIC PHARMACEUTICALS, INC.
Model SP 51-031
Catalog number 51-031
Device description 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. Paste/Paste Dual-Barrel, Labeled.
Published 2016-08-03
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name EMA Cement, Dental
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EMA Cement, Dental Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status D801SP510311 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Glass ionomer dental cement A non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between an aluminosilicate glass powder and an aqueous solution of a polyalkenoic acid. It typically includes some additional fillers, and may include setting substances that are in the minority (e.g., resin, metal). After application, this device cannot be reused.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 0 Degrees Fahrenheit 75 Degrees Fahrenheit
Regulatory Flags# DUNS number 096010525 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published D801ID70125BI1 International Dental Supply Gel Etch Dental Conditioner ID 70-125 BI 70-125 2016-08-11 D801SP50013B1 SciPharm Dental Etching Agent Bottle SP 50-013 B 50-013 2016-07-06 D801SP50013N1 SciPharm Dental Etching Agent Bottle, Non-Boxed SP 50-013 N 50-013 2016-07-07 D801SP701211 SciPharm Gel Etch Dental Conditioner SP 70-121 70-121 2016-08-11 D801SP70125B1 SciPharm Gel Etch Dental Conditioner SP 70-125 B 70-125 2016-08-11 D801SP70125N1 SciPharm Gel Etch Dental Conditioner SP 70-125 N 70-125 2016-08-11 D801SP70125RB1 SciPharm Gel Etch Dental Conditioner SP 70-125 RB 70-125 2016-08-11 D801SP70125SB1 SciPharm Gel Etch Dental Conditioner SP 70-125 SB 70-125 2016-08-11 D801SP70128B1 SciPharm Gel Etch Dental Conditioner SP 70-125 B 70-128 2016-08-11 D801SP7012B1 SciPharm Gel Etch Dental Conditioner SP 70-12 B 70-12 2016-08-10 D801SP7012N1 SciPharm Gel Etch Dental Conditioner SP 70-12 N 70-12 2016-08-10 D801SP7012RB1 SciPharm Gel Etch Dental Conditioner SP 70-12 RB 70-12 2016-08-10 D801SP7012SB1 SciPharm Gel Etch Dental Conditioner SP 70-12 SB 70-12 2016-08-10 D801SP70130B1 SciPharm Gel Etch Dental Conditioner SP 70-130 B 70-130 2016-08-11 D801SP70130N1 SciPharm Gel Etch Dental Conditioner SP 70-130 N 70-130 2016-08-11 D801SP70143B1 SciPharm Gel Etch Dental Conditioner SP 70-143 B 70-143 2016-08-11 D801SP70143N1 SciPharm Gel Etch Dental Conditioner SP 70-143 N 70-143 2016-08-11 D801SP7014B1 SciPharm Gel Etch Dental Conditioner SP 70-14 B 70-14 2016-08-11 D801SP7014N1 SciPharm Gel Etch Dental Conditioner SP 70-14 N 70-14 2016-08-11 D801SP5505B1 SciPharm Diamond Luster Polishing Paste SP 55-05 B 55-05 2016-08-08
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