FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
10381780506737
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
310-16300
Catalog number
310-16300
Device description
Zinc Oxide, 1 lb. (0.45kg) Bottle
Published
2018-09-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
10381780506737PrimaryGS10
H834310163000SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178050673710381780506737

GMDN Terms#

Term, Definition table
TermDefinition
Zinc oxide eugenol dental cementA 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 (e.g., rosin/colophony). After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool dry location

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
081277700
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780156802Integra® Ruggles®-Redmond™RN2528RN25282016-08-14
10381780167075Integra® Jarit®500105500-1052018-04-09
10381780394761Integra® Jarit®500100500-1002018-04-09
10381780394778Integra® Jarit®500110500-1102018-04-09
10381780394808Integra® Jarit®500135500-1352018-04-09
10381780435860Integra® Miltex®30-3030-302018-01-24
10381780435907Integra® Miltex®30-5530-552018-01-24
10381780435952Integra® Miltex®30-6230-622018-01-24
10381780488248Integra® Miltex®MH30-10MH30-102018-08-20
10381780488262Integra® Miltex®MH30-15MH30-152018-08-20
10381780488279Integra® Miltex®MH30-20MH30-202018-08-20
10381780488286Integra® Miltex®MH30-30MH30-302018-08-20
10381780488293Integra® Miltex®MH30-50MH30-502018-08-20
10381780488361Integra® Miltex®MH30-55MH30-552018-08-20
10381780488378Integra® Miltex®MH30-60MH30-602018-08-20
10381780488385Integra® Miltex®MH30-62MH30-622018-08-20
10381780500490Integra® Miltex®30-1030-102018-09-18
10381780500520Integra® Miltex®30-1530-152018-09-18
10381780500605Integra® Miltex®30-2030-202018-09-18
10381780077244Integra®371231037123102018-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08806383591706DIACEM 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
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