FDA.reportPublic FDA data

DIACEM TEMPNE

Primary DI
08806383591706
Brand
DIACEM TEMPNE
Company
DiaDent Group International
Model
DIACEM TEMPNE 10g(Type S)
Catalog number
A2004-6913
Device description
This product is a non-eugenol type dental adhesive cement that corresponds to type 1 (for temporary cementation) according to the classification of ISO3107. Zinc oxide reacts with 2-ethoxybenzoic acid to have relatively low adhesion and strength and is used for temporary bonding.
Published
2026-05-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EMBZinc Oxide Eugenol

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMBZinc Oxide EugenolDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806383591706PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806383591706088063835917068806383591706

GMDN Terms#

Term, Definition table
TermDefinition
Ethoxy benzoic acid dental cementA non-sterile, non-aqueous substance intended for professional use as a dental cement (e.g., luting agent, liner, base) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between ethoxy benzoic acid (EBA) and zinc oxide (ZnO). It typically includes some additional fillers/components. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry and away from Sunlight
Storage Environment Temperature2 Degrees Celsius27 Degrees Celsius

Regulatory Flags#

DUNS number
687789453
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806383591690DIACEM TEMPNEDIACEM TEMPNE 3g(Type S)A2004-69122026-05-13
06944835131147DIA-X FILE21mm D1/D4 Asst571-S1912026-02-20
06944835131154DIA-X FILE25mm D1/D4 Asst571-S2912026-02-20
06944835131338DIA-X FILE19mm/21mm DX/D3 Asst571-S1922026-02-20
06944835131345DIA-X FILE19mm/25mm DX/D3 Asst 571-S2912026-02-20
06944835173291DIA-X FILE19mm DX571-S1002026-02-20
06944835173307DIA-X FILE21mm D1 571-S1012026-02-20
06944835173314DIA-X FILE21mm D2 571-S1022026-02-20
06944835173321DIA-X FILE21mm D3571-S1032026-02-20
06944835173338DIA-X FILE21mm D4571-S1042026-02-20
06944835173345DIA-X FILE21mm D5 571-S1052026-02-20
06944835173369DIA-X FILE21mm D6571-S1062026-02-20
06944835173376DIA-X FILE21mm D7 571-S1072026-02-20
06944835173383DIA-X FILE25mm D1571-S2012026-02-20
06944835173390DIA-X FILE25mm D2571-S2022026-02-20
06944835173406DIA-X FILE25mm D3571-S2032026-02-20
06944835173413DIA-X FILE25mm D4571-S2042026-02-20
06944835173420DIA-X FILE25mm D5571-S2052026-02-20
06944835173444DIA-X FILE25mm D6571-S2062026-02-20
06944835173451DIA-X FILE25mm D7571-S2072026-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806383591690DIACEM TEMPNEDiaDent Group InternationalEMB2026-05-13
00817169021421Joy by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEMB2026-03-11
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D161280150AxioIRM 75g powder 40ml liquidAxiodent Inc.EMB2024-09-29
D161280160AxioIRM XS 38g powder 14ml 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
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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
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10852253006257Power Temp Mini Syringe KitJ. MORITA U.S.A., INCEMB2023-06-07
D95600ZOERF0Zoer ReinforcedD.S.I DENTAL SOLUTIONS LTDEMB2023-02-15
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D967300150ZinconolPREVEST DENPRO LIMITEDEMB2022-12-19
D96730015A09ZinconolPREVEST DENPRO LIMITEDEMB2022-12-19
D9673001600ZitempPREVEST DENPRO LIMITEDEMB2022-12-19
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