FDA.reportPublic FDA data

Re-fine Bright

Primary DI
04582275711608
Brand
Re-fine Bright
Company
YAMAHACHI DENTAL MFG.,CO.
Model
17L
Published
2023-04-17
Public version status
New
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
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
04582275711608PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04582275711608045822757116084582275711608

GMDN Terms#

Term, Definition table
TermDefinition
Dental prosthesis restorative material, unfilled resinA material designed to repair dental prostheses that consists of an unfilled polymeric resin. The material works as a bonding agent to provide a strong and long-lasting attachment to the segments of a broken or cracked prosthesis; it typically consists of a single or two-component polymeric (e.g., acrylic) resin that usually becomes a solid polymer when treated with light and/or heat. The material is used in a dentist?s office or dental laboratory to repair fixed dental prostheses and/or partial or total dentures.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
693430001
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D080XXTRR05KGXXW050TrinDy Try-In0.5KG,W0.52026-04-27
D080XXTRR05KGXXXA10TrinDy Try-In0.5KG,A12026-04-27
D080XXTRR05KGXXXA20TrinDy Try-In0.5KG,A22026-04-27
D080XXTRRX1KGXXW050TrinDy Try-In1KG,W0.52026-04-27
D080XXTRRX1KGXXXA10TrinDy Try-In1KG,A12026-04-27
D080XXTRRX1KGXXXA20TrinDy Try-In1KG,A22026-04-27
D080XXTRS05KGXXCLE0TrinDy Surgical Guide0.5KG,CLEAR2026-04-27
D080XXTRSX1KGXXCLE0TrinDy Surgical Guide1KG,CLEAR2026-04-27
D080XXTRT05KGXXBLU0TrinDy Tray0.5KG,BLUE2026-04-27
D080XXTRT05KGXXPNK0TrinDy Tray0.5KG,PINK2026-04-27
D080XXTRTX1KGXXBLU0TrinDy Tray1KG,BLUE2026-04-27
D080XXTRTX1KGXXPNK0TrinDy Tray1KG,PINK2026-04-27
D080XXGCO15MLXXXXX0GLOSSY COAT15ML2026-04-10
D080XXPMD101M13VPN0PMMA DISK1PC,13MM*101MM,V PINK2023-10-04
D080XXPMD101M20VPN0PMMA DISK1PC,20MM*101MM,V PINK2023-10-04
D080XXPMD95MM22VPN0PMMA DISK1PC,22MM*95MM,V PINK2023-10-04
D080XXPMD95MM25VPN0PMMA DISK1PC,25MM*95MM,V PINK2023-10-04
D080XXPMD95MM30VPN0PMMA DISK1PC,30MM*95MM,V PINK2023-10-04
D080XXPMD95MM20VPN0PMMA DISK1PC,20MM*95MM,V PINK2023-10-03
D080XXPMD985M1735V0PMMA DISK1PC,17.5MM+17.5MM*98.5MM,A3.5+V PINK2023-10-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D14307560147448040Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29
D14307560147448110Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29
D14307560147448280Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29
D14307560147448350Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29
D14307560147449650Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29
D14307560147450090Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29
D14307560147450160Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29
D14307560147451840Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29
07615208482775ProBase Hot / ProBase ColdIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-04-30
08056640078369major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-04-27
08056640078857major.repairMAJOR PRODOTTI DENTARI SPAEBI2026-04-27
07701126631194Opti-Cryl Pour Acrylic Original X 22 lbPRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S AEBI2026-04-23
EPRC66100851dima Print Denture Base 2pro3dure medical GmbHEBI2025-07-31
08435288443584IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443591IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443614IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443645IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443669IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443690IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443607IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443621IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443638IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443652IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443676IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443683IDODENTINEUNION DENTAL SAEBI2024-11-27
EPOLPMMP10090Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10100Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10110Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10120Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10130Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17