CROWN PX

GUDID 04582276045825

YAMAHACHI DENTAL MFG.,CO.

Resin artificial teeth
Primary Device ID04582276045825
NIH Device Record Key991ecdef-748f-4b35-823f-8913f5b751c7
Commercial Distribution StatusIn Commercial Distribution
Brand NameCROWN PX
Version Model NumberC51, C1
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
GS104582276045825 [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 Date2018-01-27

On-Brand Devices [CROWN PX]

04582276122359S71, C2
04582276122243T61S, W0.5
04582276051246T61, W0.5
04582276051239T61S, D4
04582276051222T61S, D3
04582276051215T61S, D2
04582276051208T61S, C4
04582276051192T61S, C3
04582276051185T61S, C2
04582276051178T61S, C1
04582276051161T61S, B4
04582276051154T61S, B3
04582276051147T61S, B2
04582276051130T61S, B1
04582276051123T61S, A4
04582276051116T61S, A3.5
04582276051109T61S, A3
04582276051093T61S, A2
04582276051086T61S, A1
04582276051079T61, D4
04582276051062T61, D3
04582276051055T61, D2
04582276051048T61, C4
04582276051031T61, C3
04582276051024T61, C2
04582276051017T61, C1
04582276051000T61, B4
04582276050997T61, B3
04582276050980T61, B2
04582276050973T61, B1
04582276050966T61, A4
04582276050959T61, A3.5
04582276050942T61, A3
04582276050935T61, A2
04582276050928T61, A1
04582276050911T51, W0.5
04582276050904T51S, W0.5
04582276050898T51S, D4
04582276050881T51S, D3
04582276050874T51S, D2
04582276050867T51S, C4
04582276050850T51S, C3
04582276050843T51S, C2
04582276050836T51S, C1
04582276050829T51S, B4
04582276050812T51S, B3
04582276050805T51S, B2
04582276050799T51S, B1
04582276050782T51S, A4
04582276050775T51S, A3.5

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