FDA.report

Keystone Industries

Primary DI
H66811475771
Brand
Keystone Industries
Company
Keystone Industries
Model
1147577
Catalog number
1147577
Device description
Zinc Oxide Powder USP 1.5 oz (42g)
Published
2022-11-30
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

Contact Domains

Product Codes

CodeName
EMBZINC OXIDE EUGENOL

Product Code Classifications

CodeDeviceSpecialtyClass
EMBZinc Oxide EugenolDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
H66811475771PrimaryHIBCC0

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

Contacts

PhoneEmail
+1(800)333-3131tschwear@keystoneind.com

Regulatory Flags

DUNS number
073503117
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
H66842204401Carbon 422044042304402025-08-28
H66842204411Carbon 422044142304412025-08-28
H66842204421Carbon 422044242304422025-08-28
H66842004331KeyPrint420043342004332025-01-07
H66842004341KeyPrint420043442004342025-01-07
H66842204301KeyPrint422043042204302025-01-07
H66842204311KeyPrint422043142204312025-01-07
H66842204321KeyPrint 422043242204322025-01-07
H66842204331KeyPrint422043342204332025-01-07
H66842204341KeyPrint422043442204342025-01-07
H66842004301KeyPrint420043042004302024-12-17
H66842004311KeyPrint420043142004312024-12-17
H6684200432KeyPrint420043242004322024-12-17
H66842000100KeyPrint420001042000102024-06-25
H6683524850Omni24-4294524-429452024-06-21
H6683524860Omni24-4294624-429462024-06-21
H6683524870Omni24-4294724-429472024-06-21
H6683524880Omni24-4294824-429482024-06-21
H66841101412KeyPrint422014142201412023-09-25
H66842201512KeyPrint422015142201512023-09-25

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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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
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
H66811475781Keystone IndustriesKeystone IndustriesEMB2022-11-30
H66860705001MizzyKeystone IndustriesEMB2022-11-30
H66860705101MizzyKeystone IndustriesEMB2022-11-30