FDA.reportPublic FDA data

Zinconol

Primary DI
D967300150
Brand
Zinconol
Company
PREVEST DENPRO LIMITED
Model
15g powder
Catalog number
30015
Published
2022-12-19
Public version status
Update
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
D967300150PrimaryHIBCC0

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
859546940
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D967410010Rotoflex Gold files triangular cross section 21mm pack of six410012026-04-29
D967410020Rotoflex Gold files triangular cross section 25mm pack of six410022026-04-29
D967410030Rotoflex Gold files triangular cross section 31mm pack of six410032026-04-29
D967410040Rotoflex Gold files triangular cross section 17/0421mm pack of six410042026-04-29
D967410050Rotoflex Gold files triangular cross section 17/0425mm pack of six410052026-04-29
D967410060Rotoflex Gold files triangular cross section 20/0421mm pack of six410062026-04-29
D967410070Rotoflex Gold files triangular cross section 20/0425mm pack of six410072026-04-29
D967410080Rotoflex Gold files triangular cross section 25/0421mm pack of six410082026-04-29
D967410090Rotoflex Gold files triangular cross section 25/0425mm pack of six410092026-04-29
D967410100Rotoflex Gold files triangular cross section 30/0421mm pack of six410102026-04-29
D967410110Rotoflex Gold files triangular cross section 30/0425mm pack of six410112026-04-29
D967410120Rotoflex Gold files triangular cross section 35/0421mm pack of six410122026-04-29
D967410130Rotoflex Gold files triangular cross section 35/0425mm pack of six410132026-04-29
D967410140Rotoflex Gold files triangular cross section 40/0421mm pack of six410142026-04-29
D967410150Rotoflex Gold files triangular cross section 40/0425mm pack of six410152026-04-29
D967410160Rotoflex Gold files triangular cross section 20/0621mm pack of six410162026-04-29
D967410170Rotoflex Gold files triangular cross section 20/0625mm pack of six410172026-04-29
D967410180Rotoflex Gold files triangular cross section 25/0621mm pack of six410182026-04-29
D967410190Rotoflex Gold files triangular cross section 25/0625mm pack of six410192026-04-29
D967410200Rotoflex Gold files triangular cross section 30/0621mm pack of six410202026-04-29

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
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
D96730015A09ZinconolPREVEST DENPRO LIMITEDEMB2022-12-19
D9673001600ZitempPREVEST DENPRO LIMITEDEMB2022-12-19
H66811475771Keystone IndustriesKeystone IndustriesEMB2022-11-30
H66811475781Keystone IndustriesKeystone IndustriesEMB2022-11-30