FDA.reportPublic FDA data

Olympian-M Temporary Cement, Syringe Part B

Primary DI
D83600030
Brand
Olympian-M Temporary Cement, Syringe Part B
Company
DENT ZAR, INC.
Model
0003
Catalog number
0003
Device description
Olympian M is used for cementating temporary crowns and splints. Retention of temporary crowns, sealing dressing in teeth during root canal therapy procedures.Trial cementation of permanent restorations prior to final insertion.Testing of interproximal contacts prior to final placement.
Published
2016-09-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
EMACement, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMACement, DentalDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D83600030PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
789664455
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D83600400Dental Etchant (Enamel Conditioner), 12g Syringe004000402016-09-04
D83600540Dental Etchant (Enamel Conditioner), 1kg Bottle005400542016-09-04
D83600210Z Bond-Visible Light Cure One-Step Bonding Adhesive002100212016-09-03
D83600500Bonding Agent Visible Light Cure005000502016-09-03
D83610181Bonding Agent (Self-Cure) Part A & Part B101810182016-09-03
D836TKJGX4Polishers120242022-03-08
D836PSLFH9LED Curing Light120232022-03-07
D836QXGZK2Dental Diamond Burs120222022-03-07
D83600080Acorn Nano Micro Hybrid-Syringe Shade A1000800082016-09-02
D83600090Acorn Nano Micro Hybrid-Syringe Shade A2000900092016-09-02
D83600100Acorn Nano Micro Hybrid-Syringe Shade A3001000102016-09-02
D83600110Acorn Nano Micro Hybrid-Syringe Shade B2001100112016-09-02
D83600120Acorn Nano Micro Hybrid-Syringe Shade A4001200122016-09-02
D83600130Acorn Nano Micro Hybrid-Syringe Shade B3001300132016-09-02
D83600140Acorn Nano Micro Hybrid-Syringe Shade C2001400142016-09-02
D83600150Acorn Nano Micro Hybrid-Syringe Shade D3001500152016-09-02
D83600160Acorn Nano Micro Hybrid-Syringe Shade A3.5001600162016-09-02
D83600170Acorn Nano Micro Hybrid-Syringe Shade C3001700172016-09-02
D83600180Acorn Nano Micro Hybrid-Syringe Shade B1001800182016-09-02
D83600190Acorn Nano Micro Hybrid-Syringe Incisal001900192016-09-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810118108082NuSmile BioCemNUSMILE, LTD.EMA2026-09-22
00766054002956CEMPOWERESSENTIAL DENTAL SYSTEMS, INC.EMA2026-09-21
00195062162565Cement-ItKerr CorporationEMA2026-07-29
00195062162572Cement-ItKerr CorporationEMA2026-07-29
00195062162589Cement-ItKerr CorporationEMA2026-07-29
08809911118529NuSmile NuCemNUSMILE, LTD.EMA2026-07-21
08809911118550NuSmile NuCemNUSMILE, LTD.EMA2026-07-21
08806383591737DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591751DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591775DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591959DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591966DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591973DIA-CEMDiaDent Group InternationalEMA2026-07-20
04548162300836ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
04548162300843ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
04548162300850ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
04548162300867ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
04548162344113ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
08809262953602EsCemSpident Co., Ltd.EMA2026-04-29
08809262953619EsCemSpident Co., Ltd.EMA2026-04-29
08809262953626EsCemSpident Co., Ltd.EMA2026-04-29
08809262959208EsCem RMGISpident Co., Ltd.EMA2026-04-20
08809262959215EsCem RMGISpident Co., Ltd.EMA2026-04-20
08809262959222EsCem RMGISpident Co., Ltd.EMA2026-04-20
08809262959239EsCem RMGISpident Co., Ltd.EMA2026-04-20
08809911118505NuSmile NuCemNUSMILE, LTD.EMA2026-04-14
08809911118512NuSmile NuCemNUSMILE, LTD.EMA2026-04-14
08809911118536NuSmile NuCemNUSMILE, LTD.EMA2026-04-08
08809911118543NuSmile NuCemNUSMILE, LTD.EMA2026-04-08
07615208292855Speedcem 100IVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2024-10-14