FDA.reportPublic FDA data

TEMREX SATIN POLISHING PASTE

Primary DI
00850015110474
Brand
TEMREX SATIN POLISHING PASTE
Company
TEMREX CORPORATION
Model
5200, 5210
Device description
For restoring the original smoothness and polishing of dental porcelain crowns, inlays, onlays, veneers and bridges; for both intra and extra oral use.
Published
2022-03-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EJRAgent, Polishing, Abrasive, Oral Cavity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJRAgent, Polishing, Abrasive, Oral CavityDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K852157000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K852157000TEMREX DENTAL POLISHING PASTEScientific Pharmaceuticals, Inc.1985-07-19EJR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850015110474PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850015110474008500151104748500151104740850015110474

GMDN Terms#

Term, Definition table
TermDefinition
DentifriceA substance, or combination of substances, intended to be used for cleaning the accessible surfaces of the teeth by polishing. It typically includes mild abrasives, detergents, flavouring agents, and other products, and is normally supplied as a toothpaste or tooth powder intended for self-application using a toothbrush, or formulated to be applied by dental professionals using a handpiece attachment. 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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17310236901089ProphyCare HApDirecta ABEJR2025-09-01
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07615208479218VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208479225VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208479232VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208479249VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208479379VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208480054VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
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