FDA.reportPublic FDA data

RelyX™ Temp E

Primary DI
J001702011153370
Brand
RelyX™ Temp E
Company
3M Deutschland GmbH
Model
35014
Catalog number
35014
Device description
3M™ ESPE™ RelyX™ Temp E Zinc Oxide Eugenol Temporary Cement Refill, 35014
Published
2016-09-24
Public version status
Update
Distribution status
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
J001702011153370PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Fatty acid dental cementA non-sterile, non-aqueous substance containing fatty acids typically with a mixture of oxides or hydroxides of zinc, magnesium, and/or calcium, that cures upon the acid/base reaction of its components and is intended to be used in a professional setting for the temporary luting of prefabricated dental crowns and bridges, but may also be used for the temporary filling of small cavities. It is typically available as a two-component device that can be hand mixed or auto-mixed (using a dispenser with mixing nozzle) into a paste. After application, this device cannot be reused.

Contacts#

Phone, Email table
PhoneEmail
+1(800)634-22493Mhealthcarecompliance@mmm.com

Regulatory Flags#

DUNS number
315731711
Device count
1
Lot or batch
true
Expiration date on label
true

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507073878180623M™ Tegaderm™1685NS1685NS2026-05-08
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08806383591706DIACEM TEMPNEDiaDent Group InternationalEMB2026-05-13
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D161280170AxioZi-Temp 15g powder 10ml liquidAxiodent Inc.EMB2024-09-29
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07898561542229MaquiraMaquira Industria de Produtos Odontologicos S/AEMB2024-08-07
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