FDA.reportPublic FDA data

Zoer Reinforced

Primary DI
D95600ZOERF0
Brand
Zoer Reinforced
Company
D.S.I DENTAL SOLUTIONS LTD
Model
ZOER-RF
Published
2023-02-15
Public version status
Update
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
EMBZinc Oxide Eugenol

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMBZinc Oxide EugenolDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D95600ZOERF0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
532290720
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D9560ZOERQS0Zoer QuickZOER-QS2023-02-15
D9560SILFLO5Sil-FlowSILFLO52025-06-26
D9560000ULA0UniLite Universal Composite 4g Bleach A0UL-A02024-06-26
D9560000ULA1UniLite Universal Composite 4g A1UL-A12024-06-26
D9560000ULA2UniLite Universal Composite 4g A2UL-A22024-06-26
D9560000ULA3UniLite Universal Composite 4g A3UL-A32024-06-26
D9560000ULB1UniLite Universal Composite 4g B1UL-B12024-06-26
D9560000ULB2UniLite Universal Composite 4g B2UL-B22024-06-26
D9560000ULB3UniLite Universal Composite 4g B3UL-B32024-06-26
D956000ULA35UniLite Universal Composite 4g A3.5UL-A352024-06-26
D956000ULUD0UniLite Universal Composite 4g Opaque UniversalUL-UD2024-06-26
D956000USP800UltraSil Putty 800US-P8002024-06-26
D95600ULFNA0UniLite Flow 2 x 2g Bleach A0ULFN-A02024-06-26
D95600ULFNA1UniLite Flow 2 x 2g Composite A1ULFN-A12024-06-26
D95600ULFNA2UniLite Flow 2 x 2g Composite A2ULFN-A22024-06-26
D95600ULFNA3UniLite Flow 2 x 2g Composite A3ULFN-A32024-06-26
D95600ULFNB1UniLite Flow 2 x 2g Composite B1ULFN-B12024-06-26
D95600ULFNB2UniLite Flow 2 x 2g Composite B2ULFN-B22024-06-26
D95600ULFNB3UniLite Flow 2 x 2g Composite B3ULFN-B32024-06-26
D95600ULFNS0UniLite Flow KitULFN-S2024-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806383591690DIACEM TEMPNEDiaDent Group InternationalEMB2026-05-13
08806383591706DIACEM TEMPNEDiaDent Group InternationalEMB2026-05-13
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
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
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
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