FDA.reportPublic FDA data

YAMAHACHI PMMA DISK

Primary DI
04582275718881
Brand
YAMAHACHI PMMA DISK
Company
YAMAHACHI DENTAL MFG.,CO.
Model
98.5mm*25mm, V PINK
Published
2018-06-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K172683000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172683000Yamahachi Pink CAD/CAM DiskYAMAHACHI DENTAL MFG., Co.2018-01-16EBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04582275718881PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04582275718881045822757188814582275718881

GMDN Terms#

Term, Definition table
TermDefinition
Dental prosthesis fabrication material, polymerA dental material made of a synthetic polymer [e.g., polyetheretherketone (PEEK)] intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using computer-aided design/computer-aided manufacturing (CAD/CAM) technology.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D0804SNEAZ107ULXD30NEW ACE/EFUCERA AC 4 PLATE SAMPLE28*1SETS,S4L432,UL,D32026-08-25
D0804SNEAZ129ULA350NEW ACE/EFUCERA AC 4 PLATE SAMPLE28*1SETS,S5L634,UL,A3.52026-08-25
D0804SNEAZ129ULXA20NEW ACE/EFUCERA AC 4 PLATE SAMPLE28*1SETS,S5L634,UL,A22026-08-25
D0804SNEAZ129ULXA30NEW ACE/EFUCERA AC 4 PLATE SAMPLE28*1SETS,S5L634,UL,A32026-08-25
D0804SNEAZ129ULXB20NEW ACE/EFUCERA AC 4 PLATE SAMPLE28*1SETS,S5L634,UL,B22026-08-25
D0804SNEAZ129ULXB30NEW ACE/EFUCERA AC 4 PLATE SAMPLE28*1SETS,S5L634,UL,B32026-08-25
D0804SNEAZ129ULXD30NEW ACE/EFUCERA AC 4 PLATE SAMPLE28*1SETS,S5L634,UL,D32026-08-25
D0804SNEAZ144ULW050NEW ACE/EFUCERA AC 4 PLATE SAMPLE28*1SETS,S6L734,UL,W0.52026-08-25
D0804SNEAZ144ULXA10NEW ACE/EFUCERA AC 4 PLATE SAMPLE28*1SETS,S6L734,UL,A12026-08-25
D0804SNEAZ144ULXA20NEW ACE/EFUCERA AC 4 PLATE SAMPLE28*1SETS,S6L734,UL,A22026-08-25
D0804SNEAZ144ULXA30NEW ACE/EFUCERA AC 4 PLATE SAMPLE28*1SETS,S6L734,UL,A32026-08-25
D0804SNEAZ144ULXB10NEW ACE/EFUCERA AC 4 PLATE SAMPLE28*1SETS,S6L734,UL,B12026-08-25
D0804SNEAZ155ULXA10NEW ACE/EFUCERA AC 4 PLATE SAMPLE28*1SETS,S7L1034,UL,A12026-08-25
D0804SNEAZ155ULXA20NEW ACE/EFUCERA AC 4 PLATE SAMPLE28*1SETS,S7L1034,UL,A22026-08-25
D0804SNEAZ155ULXA30NEW ACE/EFUCERA AC 4 PLATE SAMPLE28*1SETS,S7L1034,UL,A32026-08-25
D0804SNEAZ155ULXB10NEW ACE/EFUCERA AC 4 PLATE SAMPLE28*1SETS,S7L1034,UL,B12026-08-25
D0804SNEAZ167ULA350NEW ACE/EFUCERA AC 4 PLATE SAMPLE28*1SETS,S8L1136,UL,A3.52026-08-25
D0804SNEAZ167ULXA20NEW ACE/EFUCERA AC 4 PLATE SAMPLE28*1SETS,S8L1136,UL,A22026-08-25
D0804SNEAZ167ULXA30NEW ACE/EFUCERA AC 4 PLATE SAMPLE28*1SETS,S8L1136,UL,A32026-08-25
D0804SNEAZ167ULXA40NEW ACE/EFUCERA AC 4 PLATE SAMPLE28*1SETS,S8L1136,UL,A42026-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
07615208585766IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
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