Home GUDID 00858290006437 Smart Advantage GI A1 and A2 Combo kit 30 ampules
Primary DI 00858290006437
Brand Smart Advantage GI A1 and A2 Combo kit 30 ampules
Company ELEVATE ORAL CARE, LLC
Model 675COMB00
Device description Smart Advantage GI A1 and A2 Combo kit 30 ampules
Published 2019-10-14
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
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 00858290006420 Package GS1 15 In Commercial Distribution 00858290006437 Package GS1 15 In Commercial Distribution 00858290006352 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00858290006420 00858290006420 858290006420 0858290006420 00858290006437 00858290006437 858290006437 0858290006437 00858290006352 00858290006352 858290006352 0858290006352
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.
Regulatory Flags# DUNS number 002863526 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00858290006987 Allday Oral Moisturizing Rinse, 10oz Bottle 626MR1010 2026-05-01 00858290006970 FluoriMax 2.5% NaF demo pack 630FMFT04 2026-01-28 00858290006802 Advantage Arrest 635GE3000 2025-07-21 00858290006819 Advantage Arrest 635GSP050 2025-07-21 00858290006826 Advantage Arrest 635GSP050 2025-07-21 00858290006956 Advantage Arrest Advantage Arrest SDF 38% Gel Syringe 2.8ml Kit 635GEL280 2025-06-11 00858290006734 FluoriMax Cotton Candy Flow Through Ampoule 70 pack 630007022 2024-12-12 00858290006918 Papacarie Papacarie Syringe 610PAP100 2024-12-12 00858290006932 Povi-One Povi-One/FluoriMax Varnish BG Convenience 640POFM80 2024-12-12 00858290006659 Elevate Tongue Cleaner Metal 6pk 655METAL6 2021-07-28 00858290006444 Smart Advantage GI Sample A1 and A2 pk 675UD0200 2019-06-10 00858290006543 Denteshield Primer 3ml Kit 685PRM300 2020-04-01 00858290006550 Denteshield Primer 7ml Kit 685PRM700 2020-04-01 00858290006369 Smart Advantage GI A1 ampule 575CAPA1S 2019-06-10 00858290006376 Smart Advantage GI A2 ampoule 575CAPA2S 2019-06-10 00858290006352 Smart Advantage GI A1 and A2 Combo kit 30 ampules 675COMB00 2019-10-14 00858290006314 Tooth Print Wafer Sample Pack 660TPSAMP 2019-05-30 00858290006031 Elevate Tongue Cleaner Pink 655PINK00 2019-01-23 00858290006598 DenteShield Sample Opaque with Fluoride 685DSSAMP 2020-06-11 00858290006529 DenteShield Pit and Fissure Sealant Kit with Fluoride Clear 685PITFTC 2020-04-01
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