FDA.reportPublic FDA data

PMMA DISK

Primary DI
D080XXPMD985M30VPN0
Brand
PMMA DISK
Company
YAMAHACHI DENTAL MFG.,CO.
Model
1PC,30MM*98.5MM,V PINK
Published
2023-10-03
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
EBGCrown And Bridge, Temporary, Resin
EBIResin, Denture, Relining, Repairing, Rebasing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2
EBIResin, Denture, Relining, Repairing, RebasingDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151764000
K172683000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151764000YAMAHACHI PMMA DISKSYamahachi Dental Products USA, Inc.2015-11-23EBG
K172683000Yamahachi Pink CAD/CAM DiskYAMAHACHI DENTAL MFG., Co.2018-01-16EBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D080XXPMD985M30VPN0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Temporary dental crown/bridge resinA material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.

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
06942201762285FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201762377FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201762476FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774288FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774387FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774479FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774578FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774769FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774950FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774967FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774981FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775056FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775155FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775179FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775230FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775247FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775339FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775346FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775438FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775537FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775728FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
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