FDA.reportPublic FDA data

SOLUUT PX

Primary DI
D080SSSOAXLS6XLXB40
Brand
SOLUUT PX
Company
YAMAHACHI DENTAL MFG.,CO.
Model
6*1SET,LS6,L,B4
Published
2023-09-29
Public version status
Update
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
ELMDenture, Plastic, Teeth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELMDenture, Plastic, TeethDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060507000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060507000VALPLAST YAMAHACHI TEETHValplast Intl. Corp.2006-04-07ELM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D080SSSOAXLS6XLXB40PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Resin artificial teethPrefabricated teeth made of polymer-based material for mounting on dentures. Teeth are normally delivered as sets of front teeth, upper or lower jaw, or sets of premolars and molars, upper or lower jaw, in various sizes, shapes and colours.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D0804SCENZ100ULA350CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ100ULXA10CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ100ULXA20CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ100ULXA30CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ100ULXA40CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ100ULXB10CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ100ULXB20CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ100ULXB30CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ100ULXC20CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ100ULXC30CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ100ULXD20CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ100ULXD30CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ103ULXA30CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ117ULA350CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ117ULW050CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ117ULXA10CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ117ULXA20CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ117ULXA30CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ117ULXA40CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ117ULXB10CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ117ULXB20CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ117ULXB30CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ117ULXB40CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ117ULXC10CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ117ULXC20CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ117ULXC30CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ117ULXC40CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ117ULXD20CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ117ULXD30CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ117ULXD40CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19