CROWN PX

GUDID D080SSCPXXN31XLXC10

YAMAHACHI DENTAL MFG.,CO.

Resin artificial teeth
Primary Device IDD080SSCPXXN31XLXC10
NIH Device Record Key550c3ce0-295e-4cab-98b2-4950ddc03c7e
Commercial Distribution StatusIn Commercial Distribution
Brand NameCROWN PX
Version Model Number6*1SET,N31,L,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
GS104582276046198 [Secondary]
HIBCCD080SSCPXXN31XLXC10 [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 Number5
Public Version Date2023-09-14
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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