FDA.reportPublic FDA data

Everest

Primary DI
00190707000172
Brand
Everest
Company
Ortho Organizers, Inc.
Model
490-385
Device description
Glass Ionomer Luting Cement Starter Kit
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EMACEMENT, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMACement, DentalDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190707000172PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190707000172001907070001721907070001720190707000172

GMDN Terms#

Term, Definition table
TermDefinition
Glass ionomer dental cementA 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
TypeLowHighCondition
Storage Environment Temperature50 Degrees Fahrenheit75 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
062165188
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190707192976Aria® Expressions®716-303CH-102026-08-27
00190707192983Aria® Expressions®716-304CH-102026-08-27
00190707192990Aria® Expressions®716-321CH-102026-08-27
00190707193003Aria® Expressions®716-322CH-102026-08-27
00190707193010Aria® Expressions®716-333CH-102026-08-27
00190707193027Aria® Expressions®716-351CH-HK-102026-08-27
00190707193034Aria® Expressions®716-352CH-HK-102026-08-27
00190707193041Aria® Expressions®716-359CH-HK-102026-08-27
00190707193058Aria® Expressions®716-360CH-HK-102026-08-27
00190707193065Aria® Expressions®716-369CH-HK-102026-08-27
00190707193072Aria® Expressions®716-370CH-HK-102026-08-27
00190707193089Aria® Expressions®716-389CH-HK-102026-08-27
00190707193096Aria® Expressions®716-390CH-HK-102026-08-27
00190707193102Aria® Expressions®716-393CH-HK-102026-08-27
00190707193119Aria® Expressions®716-394CH-HK-102026-08-27
00190707193126Aria® Expressions®716-399CHQ2026-08-27
00190707089078Endura Plus Instruments201-1212020-07-13
00190707000738Envision701-005-52016-09-24
00190707000745Envision701-006-52016-09-24
00190707000752Envision701-021-52016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810118108082NuSmile BioCemNUSMILE, LTD.EMA2026-09-22
00766054002956CEMPOWERESSENTIAL DENTAL SYSTEMS, INC.EMA2026-09-21
00195062162565Cement-ItKerr CorporationEMA2026-07-29
00195062162572Cement-ItKerr CorporationEMA2026-07-29
00195062162589Cement-ItKerr CorporationEMA2026-07-29
08809911118529NuSmile NuCemNUSMILE, LTD.EMA2026-07-21
08809911118550NuSmile NuCemNUSMILE, LTD.EMA2026-07-21
08806383591737DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591751DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591775DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591959DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591966DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591973DIA-CEMDiaDent Group InternationalEMA2026-07-20
04548162300836ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
04548162300843ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
04548162300850ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
04548162300867ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
04548162344113ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
08809262953602EsCemSpident Co., Ltd.EMA2026-04-29
08809262953619EsCemSpident Co., Ltd.EMA2026-04-29
08809262953626EsCemSpident Co., Ltd.EMA2026-04-29
08809262959208EsCem RMGISpident Co., Ltd.EMA2026-04-20
08809262959215EsCem RMGISpident Co., Ltd.EMA2026-04-20
08809262959222EsCem RMGISpident Co., Ltd.EMA2026-04-20
08809262959239EsCem RMGISpident Co., Ltd.EMA2026-04-20
08809911118505NuSmile NuCemNUSMILE, LTD.EMA2026-04-14
08809911118512NuSmile NuCemNUSMILE, LTD.EMA2026-04-14
08809911118536NuSmile NuCemNUSMILE, LTD.EMA2026-04-08
08809911118543NuSmile NuCemNUSMILE, LTD.EMA2026-04-08
07615208292855Speedcem 100IVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2024-10-14