TEMREX CR

Primary DI
00850015110078
Brand
TEMREX CR
Company
TEMREX CORPORATION
Model
7780
Device description
DENTAL CEMENT
Published
2020-01-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
EMACement, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMACement, DentalDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051952000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051952000EUGENONEScientific Pharmaceuticals, Inc.2005-09-07EMA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850015110078PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850015110078008500151100788500151100780850015110078

GMDN Terms#

Term, Definition table
TermDefinition
Zinc polycarboxylate dental cementA non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between zinc oxide (ZnO) and aqueous solutions of polycarboxylic acid (e.g., polyacrylic acid). It typically includes some additional fillers/components. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012072823
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850015110092GENTLE-ETCH7210 SYRINGE2020-02-13
00850015110320TEMREX GENTLE ETCH 7200 KIT2020-02-13
00850015110375GEL ETCH 6500 KIT2020-02-12
00850015110382GEL ETCH 6510 SYRINGE2020-02-12
00850015110399GEL ETCH6575 BULK KIT2020-02-12
00850015110405GEL ETCH6580 60GM. BULK SYRINGE 2020-02-12
00850015110412GEL ETCH SEMI GEL6200 13CC BOTTLE2020-02-12
00850015110429GEL ETCH SEMI GEL6300 SYRINGE2020-02-12
00850015110023TEMREX LIQUID310 1oz.2020-02-13
00850015110030TEMREX POWDER330 25gm. White2020-02-13
00850015110047TEMREX CR PLUS7790 KIT2020-02-13
00850015110122TEMREX POWDER33I Yellow 25gm.2020-02-13
00850015110139TEMREX POWDER332 Yellow/Gray 25gm.2020-02-13
00850015110146TEMREX POWDER340 White 100gm.2020-02-13
00850015110153TEMREX POWDER341 Yellow 100gm.2020-02-13
00850015110160TEMREX POWDER350 White 1lb.2020-02-13
00850015110177TEMREX POWDER351 Yellow 1lb.2020-02-13
00850015110184TEMREX POWDER352 Yellow/Gray 1lb.2020-02-13
00850015110214ZINROC POWDER430 White 25gm.2020-02-13
00850015110221ZINROC POWDER431 Lt. Yellow 25gm.2020-02-13

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