FDA.reportPublic FDA data

PMMA DISK

Primary DI
D080XXPMD985M10XD30
Brand
PMMA DISK
Company
YAMAHACHI DENTAL MFG.,CO.
Model
1PC,10MM*98.5MM,D3
Published
2023-10-02
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151764000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151764000YAMAHACHI PMMA DISKSYamahachi Dental Products USA, Inc.2015-11-23EBG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D080XXPMD985M10XD30PrimaryHIBCC0

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
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
E235DD16A1ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16A1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16A2ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16A2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16A35MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16A3MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16B1ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16B1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16B2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16B3MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16BL1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16BL2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16BL3ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16BL4MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16BLML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16BLMN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16C1ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16C1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16C2ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16C2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16D2ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16D2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16D3MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
00371347023398Advance Dental ProductsThe Atlanta Dental Supply CompanyEBG2026-07-08
00371347023404Advance Dental ProductsThe Atlanta Dental Supply CompanyEBG2026-07-08
00371347023411Advance Dental ProductsThe Atlanta Dental Supply CompanyEBG2026-07-08
EPOLPMFLAG5600PMMA CAD/CAM discPOLIDENT d.o.o.EBG2025-05-13
EPOLPMMA0230PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0310PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0390PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07