SOLUUT PX

GUDID D080SSSOACSP4XUXB10

YAMAHACHI DENTAL MFG.,CO.

Resin artificial teeth
Primary Device IDD080SSSOACSP4XUXB10
NIH Device Record Keyfd7b20c0-5338-4a45-83fe-479e03772afd
Commercial Distribution StatusIn Commercial Distribution
Brand NameSOLUUT PX
Version Model Number6*1SET,CSP4,U,B1
Company DUNS693430001
Company NameYAMAHACHI DENTAL MFG.,CO.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD080SSSOACSP4XUXB10 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELMDenture, Plastic, Teeth

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-05
Device Publish Date2023-09-27

On-Brand Devices [SOLUUT PX]

D080SSSOAXXT7XUXA106*1SET,T7,U,A1
D080SSSOAXXT6XUXA106*1SET,T6,U,A1
D080SSSOAXXT5XUXA106*1SET,T5,U,A1
D080SSSOAXXT4XUXA106*1SET,T4,U,A1
D080SSSOAXXS7XUXA106*1SET,S7,U,A1
D080SSSOAXXS6XUXA106*1SET,S6,U,A1
D080SSSOAXXS5XUXA106*1SET,S5,U,A1
D080SSSOAXXS4XUXA106*1SET,S4,U,A1
D080SSSOAXSS5XUXA106*1SET,SS5,U,A1
D080SSSOAXSS4XUXA106*1SET,SS4,U,A1
D080SSSOAXXL4XLXA406*1SET,L4,L,A4
D080SSSOAXXC7XUW0506*1SET,C7,U,W0.5
D080SSSOAXXC6XUXA106*1SET,C6,U,A1
D080SSSOAXXC5XUXA306*1SET,C5,U,A3
D080SSSOAXXC5XUXA106*1SET,C5,U,A1
D080SSSOAXSS7XUXA106*1SET,SS7,U,A1
D080SSSOAXSS6XUXA106*1SET,SS6,U,A1
D080SSSOAXXL7XLXB106*1SET,L7,L,B1
D080SSSOAXLS5XLXA106*1SET,LS5,L,A1
D080SSSOAXLS5XLW0506*1SET,LS5,L,W0.5
D080SSSOAXLS4XLXB106*1SET,LS4,L,B1
D080SSSOAXXT7XUXD406*1SET,T7,U,D4
D080SSSOAXXT7XUXD306*1SET,T7,U,D3
D080SSSOAXXT7XUXD206*1SET,T7,U,D2
D080SSSOAXXT7XUXC406*1SET,T7,U,C4
D080SSSOAXXT7XUXC306*1SET,T7,U,C3
D080SSSOAXXT7XUXC206*1SET,T7,U,C2
D080SSSOAXXT7XUXC106*1SET,T7,U,C1
D080SSSOAXXT7XUXB406*1SET,T7,U,B4
D080SSSOAXXT7XUXB306*1SET,T7,U,B3
D080SSSOAXXT7XUXB206*1SET,T7,U,B2
D080SSSOAXXT7XUXB106*1SET,T7,U,B1
D080SSSOAXXT7XUXA406*1SET,T7,U,A4
D080SSSOAXXT7XUXA306*1SET,T7,U,A3
D080SSSOAXXT7XUXA206*1SET,T7,U,A2
D080SSSOAXXT7XUW0506*1SET,T7,U,W0.5
D080SSSOAXXT7XUA3506*1SET,T7,U,A3.5
D080SSSOAXXT6XUXD406*1SET,T6,U,D4
D080SSSOAXXT6XUXD306*1SET,T6,U,D3
D080SSSOAXXT6XUXD206*1SET,T6,U,D2
D080SSSOAXXT6XUXC406*1SET,T6,U,C4
D080SSSOAXXT6XUXC306*1SET,T6,U,C3
D080SSSOAXXT6XUXC206*1SET,T6,U,C2
D080SSSOAXXT6XUXC106*1SET,T6,U,C1
D080SSSOAXXT6XUXB406*1SET,T6,U,B4
D080SSSOAXXT6XUXB306*1SET,T6,U,B3
D080SSSOAXXT6XUXB206*1SET,T6,U,B2
D080SSSOAXXT6XUXB106*1SET,T6,U,B1
D080SSSOAXXT6XUXA406*1SET,T6,U,A4
D080SSSOAXXT6XUXA306*1SET,T6,U,A3

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.