FLAT AC

GUDID 04582276027456

YAMAHACHI DENTAL MFG.,CO.

Resin artificial teeth
Primary Device ID04582276027456
NIH Device Record Keyc149ef07-789c-41f1-9e89-d9e497af2b11
Commercial Distribution StatusIn Commercial Distribution
Brand NameFLAT AC
Version Model Number32L, A2
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
GS104582276027456 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2018-01-25

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

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