FDA.reportPublic FDA data

Tru-Paque

Primary DI
D8370740030
Brand
Tru-Paque
Company
Taub Products
Model
Thinner - 16 oz (473 mL)
Catalog number
07-4003
Device description
Thinner for Tru-Paque.
Published
2023-06-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBFMaterial, Tooth Shade, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D8370740030PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental composite resinA non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume16Fluid Ounce
Total Volume473Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from open flame. See SDS.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1.201.798.5353customerservice@taubdental.com

Regulatory Flags#

DUNS number
067488114
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D8370650100FUSION-Zr - Veneer CementKit - 2 Crystal Clear - 1.2ml Syringe06-50102016-12-05
D8370650200FUSION-Zr - Veneer CementKit - 2 Opal White - 1.2ml Syringe06-50202016-12-05
D8370651050FUSION-Zr - Veneer CementCrystal Clear - 3ml Syringe06-51052016-12-05
D8370651150FUSION-Zr - Veneer CementOpal White - 3ml Syringe06-51152016-12-05
D8370655000FUSION-Zr - Veneer CementCrystal Clear - 0.6mL - Sample06-55002016-12-05
D8370655100FUSION-Zr - Veneer CementOpal White - 0.6mL - Sample06-55102016-12-05
D8370655200FUSION-Zr - Veneer CementNew White - 0.6mL - Sample06-55202016-12-05
D8374610000ZERO-G Bio Implant CementKit - 7 gm Syringe - 2pk46-10002016-12-05
D8374610050ZERO-G Bio Implant Cement7 gm Syringe - 1pc46-10052016-12-05
D8374650000ZERO-G Bio Implant Cement3.5 gm Syringe - Evaluator46-50002016-12-05
D8374710000Liquid Magic - Resin BarrierKit - 3 mL Syr - 2 pk47-10002016-12-05
D8374750000Liquid Magic - Resin Barrier1.5 mL Syr - Evaluator47-50002016-12-05
D8374810000Go-CHx Gel - 0.8% ChlorhexidineKit - 3 mL Syr - 2 pk48-10002016-12-05
D8374810050Go-CHx Gel - 0.8% Chlorhexidine3 mL Syr - 1ea.48-10052016-12-05
D8374850000Go-CHx Gel - 0.8% Chlorhexidine0.6 mL Syr - 1ea - Evaluator48-50002016-12-05
D8375210050ENERGY CTZ1 CEMENTWHITE - 5.4ML SYR52-10052025-07-14
D8375010500STELLAR DC AcrylicTooth White A2 - 5.85 gm Syringe50-10502019-03-19
D8375010600STELLAR DC AcrylicTooth White A1 - 5.85 gm Syringe50-10602019-03-19
D8375010100STELLAR DC AcrylicPink - 5.85 gm Syringe50-10102018-06-01
D8375050000STELLAR DC AcrylicPink - 5.85 gm Syringe Eval50-50002018-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00348783000931MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
00348783000955MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
00348783000979MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
00348783000993MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
00348783001044MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
00348783001051MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
06975338702916SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338702923SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338702930SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338702947SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338702992SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703005SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703012SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703029SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703074SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703081SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703098SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703104SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703357SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703364SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703371SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703388SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
00348783000917MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-01
D14307560147448040Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBF2026-05-29
D14307560147448110Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBF2026-05-29
D14307560147448280Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBF2026-05-29
D14307560147448350Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBF2026-05-29
D14307560147449650Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBF2026-05-29
D14307560147450090Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBF2026-05-29
D14307560147450160Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBF2026-05-29