FDA.reportPublic FDA data

AxioCem Conditioner

Primary DI
D161240050
Brand
AxioCem Conditioner
Company
Axiodent Inc.
Model
24005
Published
2024-10-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
D161240050PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119330625
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D161280140AxioIRM 15g powder 10ml liquid280142024-09-29
D161280150AxioIRM 75g powder 40ml liquid280152024-09-29
D161280160AxioIRM XS 38g powder 14ml liquid280162024-09-29
D161280170AxioZi-Temp 15g powder 10ml liquid280172024-09-29
D161270050AxioPrint C&B Interim500g 270052025-01-19
D161270060AxioPrint C&B Interim1000g 270062025-01-19
D161270070AxioPrint C&B Permanent500g 270072025-01-19
D161270080AxioPrint C&B Permanent1000g 270082025-01-19
D161270130AxioPrint C&B Ceramic500g 270132025-01-19
D161270140AxioPrint C&B Ceramic1000g 270142025-01-19
D161270150AxioPrint C&B Interim250g 270152025-01-19
D161270160AxioPrint C&B Permanent250g 270162025-01-19
D161270170AxioPrint C&B Ceramic250g 270172025-01-19
D161230560AxioComp NT23056 20 x 0.25g unit dose compules Shade A32024-11-12
D161230570AxioComp NT23057 20 x 0.25g unit dose compules Shade A3.52024-11-12
D161230580AxioComp NT23058 20 x 0.25g unit dose compules Shade A42024-11-12
D161230590AxioComp NT23059 20 x 0.25g unit dose compules Shade B12024-11-12
D161230600AxioComp NT23060 20 x 0.25g unit dose compules Shade B22024-11-12
D161230610AxioComp NT23061 20 x 0.25g unit dose compules Shade B32024-11-12
D161230620AxioComp NT23062 20 x 0.25g unit dose compules Shade C12024-11-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
07615208292855Speedcem 100IVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2024-10-14
07615208293470SpeedCEM / SpeedCEM PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2024-10-14
07615208293487SpeedCEM / SpeedCEM PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2024-10-14
07615208294965SpeedCEM / SpeedCEM PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2024-10-14
07615208298659Multilink Automix / Primer A+BIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2023-10-25
07615208298666Multilink Automix / Primer A+BIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2023-04-06
07615208300833Multilink Automix / Primer A+BIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2023-04-06
07615208315301Telio DesensitizerIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2022-09-29
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10386040008778GC Fuji II LC®Gc America Inc.EMA2022-07-13
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10386040008792GC Fuji II LC®Gc America Inc.EMA2022-07-13
10386040008808GC Fuji II LC®Gc America Inc.EMA2022-07-13
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10386040008822GC Fuji II LC®Gc America Inc.EMA2022-07-13