FDA.reportPublic FDA data

ProTech Plus Hard Reline and Repair Acrylic

Primary DI
D814PLUS12A0
Brand
ProTech Plus Hard Reline and Repair Acrylic
Company
PROTECH PROFESSIONAL PRODUCTS INC
Model
PLUS12A
Catalog number
PLUS12A
Device description
ProTech Plus Kit Shade 1069LO - 440 g ProTech Plus Powder and 240 ml ProTech Plus Monomer
Published
2019-05-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EBIResin, Denture, Relining, Repairing, Rebasing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131036000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131036000YAMAHACHI DENTURE BASE RESINSYamahachi Dental Manufacturing Co.2013-07-12EBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D814PLUS12A0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Denture reliner, elastic, short-termA denture relining material intended to be applied by a dentist or dental laboratory technician as a temporary coating or lining on the base or tissue-contact surface of a denture and which has elastic properties after setting. Denture relining is defined as a process of providing a new fitting surface to a denture. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117374900
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D814UBARV11AD0ProTech UBARUBARV11ADUBARV11AD2019-10-30
D814UBARV11GD0ProTech UBARUBARV11GDUBARV11GD2019-10-30
D814PLUS12AC0ProTech Plus Hard Reline and Repair AcrylicPLUS12ACPLUS12AC2019-09-24
D814PLUS12AD0ProTech Plus Hard Reline and Repair AcrylicPLUS12ADPLUS12AD2019-09-24
D814PLUS12GC0ProTech Plus Hard Reline and Repair AcrylicPLUS12GCPLUS12GC2019-09-24
D814PLUS12GD0ProTech Plus Hard Reline and Repair AcrylicPLUS12GDPLUS12GD2019-09-24
D814PLUS13GC0ProTech Plus Hard Reline and Repair AcrylicPLUS13GCPLUS13GC2019-09-24
D814PLUS13GD0ProTech Plus Hard Reline and Repair AcrylicPLUS13GDPLUS13GD2019-09-24
D814UBAR11AC0ProTech UBARUBAR11ACUBAR11AC2019-09-24
D814UBAR11AD0ProTech UBARUBAR11ADUBAR11AD2019-09-24
D814UBAR11GC0ProTech UBARUBAR11GCUBAR11GC2019-09-24
D814UBAR11GD0ProTech UBARUBAR11GDUBAR11GD2019-09-24
D814UBAR590ProTech UBARUBAR59UBAR592019-08-02
D814UBAR59A0ProTech UBARUBAR59AUBAR59A2019-08-02
D814UBAR59B0ProTech UBARUBAR59BUBAR59B2019-08-02
D814UBAR59C0ProTech UBARUBAR59CUBAR59C2019-08-02
D814UBAR59D0ProTech UBARUBAR59DUBAR59D2019-08-02
D814UBAR620ProTech UBARUBAR62UBAR622019-08-02
D814UBAR62A0ProTech UBARUBAR62AUBAR62A2019-08-02
D814UBAR62B0ProTech UBARUBAR62BUBAR62B2019-08-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08720604634242Vertex-Dental BVVertex-Dental B.V.EBI2026-09-24
06971437943618UltraPrint Flexible Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-08-27
06971437943625UltraPrint Flexible Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-08-27
06971437943649UltraPrint Flexible Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-08-27
06971437943700UltraPrint Flexible Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-08-27
06971437943748UltraPrint Flexible Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-08-27
08685313736208DentaFab3BFAB TEKNOLOJI ANONIM SIRKETIEBI2026-08-25
08685313736215DentaFab3BFAB TEKNOLOJI ANONIM SIRKETIEBI2026-08-25
08685313736222DentaFab3BFAB TEKNOLOJI ANONIM SIRKETIEBI2026-08-25
00883205041883UltraCemULTRADENT PRODUCTS, INC.EBI2026-08-22
07630813462523XPLEX BaseCandulor AGEBI2026-07-28
00850061175175Denture Base Resin V2FORMLABS OHIO INC.EBI2026-07-21
00850061175182Denture Base Resin V2FORMLABS OHIO INC.EBI2026-07-21
00850061175199Denture Base Resin V2FORMLABS OHIO INC.EBI2026-07-21
07615208585728Ivotion BaseIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585735IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
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07615208585759IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
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07615208585773IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585780IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585797IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585803IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585810IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585827IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585834IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585841IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
D14307560147448040Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29
D14307560147448110Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29