FDA.reportPublic FDA data

ProTech Soft Reline

Primary DI
D814SRC11C1
Brand
ProTech Soft Reline
Company
PROTECH PROFESSIONAL PRODUCTS INC
Model
SRC11C
Catalog number
SRC11C
Device description
8 unit ProTech Soft Reline Self Cure Kit Shade Clear - 110 gram powder, 60 ml monomer, 15 ml superbond
Published
2016-08-30
Public version status
Update
Distribution status
Not 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
K151646000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151646000ProTech PlusProtech Professional Products, Inc.2015-10-21EBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D814SRC11C1PrimaryHIBCC0

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
08056640078321major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640078338major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640078345major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640078352major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640078376major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640078802major.repairMAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640078819major.repairMAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640078826major.repairMAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640078833major.repairMAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640078840major.repairMAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640080751major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08720604634235Vertex-Dental BVVertex-Dental B.V.EBI2026-09-24
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
07615208585742IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585759IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08