FDA.reportPublic FDA data

PMMA DISK

Primary DI
D080XXPMD95MM25VPN0
Brand
PMMA DISK
Company
YAMAHACHI DENTAL MFG.,CO.
Model
1PC,25MM*95MM,V PINK
Published
2023-10-04
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
D080XXPMD95MM25VPN0PrimaryHIBCC0

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
D0804SCENZ100ULA350CROWN NS/EFUCERA NS 4 PLATE SAMPLE28*1SETS,S43SN4130,UL,A3.52026-08-19
D0804SCENZ100ULXA10CROWN NS/EFUCERA NS 4 PLATE SAMPLE28*1SETS,S43SN4130,UL,A12026-08-19
D0804SCENZ100ULXA20CROWN NS/EFUCERA NS 4 PLATE SAMPLE28*1SETS,S43SN4130,UL,A22026-08-19
D0804SCENZ100ULXA30CROWN NS/EFUCERA NS 4 PLATE SAMPLE28*1SETS,S43SN4130,UL,A32026-08-19
D0804SCENZ100ULXA40CROWN NS/EFUCERA NS 4 PLATE SAMPLE28*1SETS,S43SN4130,UL,A42026-08-19
D0804SCENZ100ULXB10CROWN NS/EFUCERA NS 4 PLATE SAMPLE28*1SETS,S43SN4130,UL,B12026-08-19
D0804SCENZ100ULXB20CROWN NS/EFUCERA NS 4 PLATE SAMPLE28*1SETS,S43SN4130,UL,B22026-08-19
D0804SCENZ100ULXB30CROWN NS/EFUCERA NS 4 PLATE SAMPLE28*1SETS,S43SN4130,UL,B32026-08-19
D0804SCENZ100ULXC20CROWN NS/EFUCERA NS 4 PLATE SAMPLE28*1SETS,S43SN4130,UL,C22026-08-19
D0804SCENZ100ULXC30CROWN NS/EFUCERA NS 4 PLATE SAMPLE28*1SETS,S43SN4130,UL,C32026-08-19
D0804SCENZ100ULXD20CROWN NS/EFUCERA NS 4 PLATE SAMPLE28*1SETS,S43SN4130,UL,D22026-08-19
D0804SCENZ100ULXD30CROWN NS/EFUCERA NS 4 PLATE SAMPLE28*1SETS,S43SN4130,UL,D32026-08-19
D0804SCENZ103ULXA30CROWN NS/EFUCERA NS 4 PLATE SAMPLE28*1SETS,S44SN4128,UL,A32026-08-19
D0804SCENZ117ULA350CROWN NS/EFUCERA NS 4 PLATE SAMPLE28*1SETS,S51N4230,UL,A3.52026-08-19
D0804SCENZ117ULW050CROWN NS/EFUCERA NS 4 PLATE SAMPLE28*1SETS,S51N4230,UL,W0.52026-08-19
D0804SCENZ117ULXA10CROWN NS/EFUCERA NS 4 PLATE SAMPLE28*1SETS,S51N4230,UL,A12026-08-19
D0804SCENZ117ULXA20CROWN NS/EFUCERA NS 4 PLATE SAMPLE28*1SETS,S51N4230,UL,A22026-08-19
D0804SCENZ117ULXA30CROWN NS/EFUCERA NS 4 PLATE SAMPLE28*1SETS,S51N4230,UL,A32026-08-19
D0804SCENZ117ULXA40CROWN NS/EFUCERA NS 4 PLATE SAMPLE28*1SETS,S51N4230,UL,A42026-08-19
D0804SCENZ117ULXB10CROWN NS/EFUCERA NS 4 PLATE SAMPLE28*1SETS,S51N4230,UL,B12026-08-19

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