FDA.report

SOLUUT PX

Primary DI
D080SSSOAXSS7XUXC10
Brand
SOLUUT PX
Company
YAMAHACHI DENTAL MFG.,CO.
Model
6*1SET,SS7,U,C1
Published
2023-09-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
ELMDenture, Plastic, Teeth

Product Code Classifications

CodeDeviceSpecialtyClass
ELMDenture, Plastic, TeethDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D080SSSOAXSS7XUXC10PrimaryHIBCC0

GMDN Terms

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

Regulatory Flags

DUNS number
693430001
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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D080SDGAC17PCSX17C0SHADE GUIDE ACSHADE GUIDE AC,17PCS,17C2025-11-19
D080SDGPX17PCSX17C0SHADE GUIDE CROWN PXSHADE GUIDE CROWN PX,17PCS,17C2025-11-19
04582276126500CROWN PXT61, B22020-06-02
04582276127125CROWN PXT51, B42020-06-11
04582276127149CROWN PXT61, B42020-06-11
04582276127422CROWN PXT41, C12020-06-12
04582276127460CROWN PXT61, C12020-06-12
04582276126401CROWN PXS51, B22020-06-02
04582276126449CROWN PXS71, B22020-06-02
04582276126456CROWN PXS81, B22020-06-02
04582276126463CROWN PXT41, B22020-06-02
04582276126470CROWN PXT41S, B22020-06-02
04582276126487CROWN PXT51, B22020-06-02
04582276126494CROWN PXT51S, B22020-06-02
04582276126517CROWN PXT61S, B22020-06-02
04582276127040CROWN PXS51, B42020-06-11
04582276127088CROWN PXS71, B42020-06-11
04582276127095CROWN PXS81, B42020-06-11
04582276127101CROWN PXT41, B42020-06-11
04582276127118CROWN PXT41S, B42020-06-11

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00817169029304Joy by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELM2026-03-11
05056079069658Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070036Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070043Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070050Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070067Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070074Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070081Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070098Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070449Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070456Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070463Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070470Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070487Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070494Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070500Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070517Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070524Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070531Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070548Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070555Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070562Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070579Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070586Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070593Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070609Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070616Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070623Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070630Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070647Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18