FLAT AC

GUDID D080SSFLAXX32XLXC40

YAMAHACHI DENTAL MFG.,CO.

Resin artificial teeth
Primary Device IDD080SSFLAXX32XLXC40
NIH Device Record Key8e6ea805-bf11-43c1-ac5a-2c872495b824
Commercial Distribution StatusIn Commercial Distribution
Brand NameFLAT AC
Version Model Number8*1SET,32,L,C4
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
HIBCCD080SSFLAXX32XLXC40 [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 Date2023-09-11
Device Publish Date2023-09-01

On-Brand Devices [FLAT AC]

0458227602772234L, B2
0458227602771534U, B2
0458227602770834L, B1
0458227602769234U, B1
0458227602768534L, A3.5
0458227602767834U, A3.5
0458227602765434L, A3
0458227602764734U, A3
0458227602762334L, A2
0458227602761634U, A2
0458227602759334L, A1
0458227602758634U, A1
0458227602755532L, B2
0458227602754832U, B2
0458227602753132L, B1
0458227602752432U, B1
0458227602751732L, A3.5
0458227602750032U, A3.5
0458227602748732L, A3
0458227602747032U, A3
0458227602745632L, A2
0458227602744932U, A2
0458227602742532L, A1
0458227602741832U, A1
0458227602733330L, B2
0458227602732630U, B2
0458227602731930L, B1
0458227602730230U, B1
0458227602729630L, A3.5
0458227602728930U, A3.5
0458227602726530L, A3
0458227602725830U, A3
0458227602723430L, A2
0458227602722730U, A2
0458227602720330L, A1
0458227602719730U, A1
D080SSFLAXX34XUXB2034,U,B2
D080SSFLAXX34XUXB1034,U,B1
D080SSFLAXX34XUXA3034,U,A3
D080SSFLAXX34XUA35034U, A3.5
D080SSFLAXX34XLXB2034,L,B2
D080SSFLAXX34XLXB1034,L,B1
D080SSFLAXX34XLXA3034,L,A3
D080SSFLAXX34XLA35034,L,A3.5
D080SSFLAXX34XLXA208*1SET,34,L,A2
D080SSFLAXX34XLXA108*1SET,34,L,A1
D080SSFLAXX32XUXB208*1SET,32,U,B2
D080SSFLAXX32XUXB108*1SET,32,U,B1
D080SSFLAXX32XUXA308*1SET,32,U,A3
D080SSFLAXX32XUXA208*1SET,32,U,A2

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