FDA.report

AxioIRM XS 38g powder 14ml liquid

Primary DI
D161280160
Brand
AxioIRM XS 38g powder 14ml liquid
Company
Axiodent Inc.
Model
28016
Published
2024-09-29
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

Related Records

Product Codes

CodeName
EMBZinc Oxide Eugenol

Product Code Classifications

CodeDeviceSpecialtyClass
EMBZinc Oxide EugenolDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D161280160PrimaryHIBCC0

GMDN Terms

TermDefinition
Zinc oxide eugenol dental cementA non-sterile, non-aqueous 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 eugenol and zinc oxide (ZnO). It typically includes some additional fillers/components. After application, this device cannot be reused.

Sterilization Methods

Method

Regulatory Flags

DUNS number
119330625
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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 DIBrandModelCatalogPublished
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
D161230630AxioComp NT23063 20 x 0.25g unit dose compules Shade C22024-11-12
D161230640AxioComp NT23064 20 x 0.25g unit dose compules Shade C32024-11-12
D161230650AxioComp NT23065 20 x 0.25g unit dose compules Shade D12024-11-12
D161230660AxioComp NT23066 20 x 0.25g unit dose compules Shade D22024-11-12
D161230670AxioComp NT23067 20 x 0.25g unit dose compules Shade D32024-11-12
D161230680AxioComp NT23068 20 x 0.25g unit dose compules Shade Incisal2024-11-12
D161230690AxioComp NT23069 20 x 0.25g unit dose compules Shade Opaque2024-11-12
D161230700AxioComp NT23070 20 x 0.25g unit dose compules Shade OA12024-11-12
D161230710AxioComp NT23071 20 x 0.25g unit dose compules Shade OA22024-11-12
D161230720AxioComp NT23072 20 x 0.25g unit dose compules Shade OA32024-11-12
D161230730AxioComp NT23073 20 x 0.25g unit dose compules Shade Extra Bl2024-11-12
D161230740AxioComp NT23074 20 x 0.25g unit dose compules Shade Bleach2024-11-12
D161230750AxioComp NT23075 20 x 0.25g unit dose compules Shade Gingival2024-11-12

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00817169021421Joy by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEMB2026-03-11
D161280140AxioIRM 15g powder 10ml liquidAxiodent Inc.EMB2024-09-29
D161280150AxioIRM 75g powder 40ml liquidAxiodent Inc.EMB2024-09-29
D161280170AxioZi-Temp 15g powder 10ml liquidAxiodent Inc.EMB2024-09-29
07898561542205MaquiraMaquira Industria de Produtos Odontologicos S/AEMB2024-08-07
07898561542212Fill Canal Liquid (10 mL) 7898561542212 Maquira MaquiraMaquira Industria de Produtos Odontologicos S/AEMB2024-08-07
07898561542229MaquiraMaquira Industria de Produtos Odontologicos S/AEMB2024-08-07
07898561542236MaquiraMaquira Industria de Produtos Odontologicos S/AEMB2024-08-07
07898561542250MaquiraMaquira Industria de Produtos Odontologicos S/AEMB2024-08-07
07898561546678MaquiraMaquira Industria de Produtos Odontologicos S/AEMB2024-08-07
07898561546685MaquiraMaquira Industria de Produtos Odontologicos S/AEMB2024-08-07
00816526020220MASTER-DENTDENTONICS INCEMB2023-10-31
00816526020237MASTER-DENTDENTONICS INCEMB2023-10-31
05021752001065Alganol Powder 90gASSOCIATED DENTAL PRODUCTS LIMITEDEMB2023-09-11
15060988910045JJ CAREJack Jack LLCEMB2023-07-15
05021752000723Eugenol B.P. Liquid 150mlASSOCIATED DENTAL PRODUCTS LIMITEDEMB2023-07-06
05021752000761Zinc Oxide B.P. Powder 150gASSOCIATED DENTAL PRODUCTS LIMITEDEMB2023-07-06
10852253006240Power Temp Cartridge KitJ. MORITA U.S.A., INCEMB2023-06-07
10852253006257Power Temp Mini Syringe KitJ. MORITA U.S.A., INCEMB2023-06-07
D95600ZOERF0Zoer ReinforcedD.S.I DENTAL SOLUTIONS LTDEMB2023-02-15
D9560ZOERQS0Zoer QuickD.S.I DENTAL SOLUTIONS LTDEMB2023-02-15
D9673001510ZinconolPREVEST DENPRO LIMITEDEMB2023-01-03
D967300160ZitempPREVEST DENPRO LIMITEDEMB2023-01-03
D967300150ZinconolPREVEST DENPRO LIMITEDEMB2022-12-19
D96730015A09ZinconolPREVEST DENPRO LIMITEDEMB2022-12-19
D9673001600ZitempPREVEST DENPRO LIMITEDEMB2022-12-19
H66811475771Keystone IndustriesKeystone IndustriesEMB2022-11-30
H66811475781Keystone IndustriesKeystone IndustriesEMB2022-11-30
H66860705001MizzyKeystone IndustriesEMB2022-11-30
H66860705101MizzyKeystone IndustriesEMB2022-11-30