CROWN PX

GUDID 04582276129471

4sets/box

YAMAHACHI DENTAL MFG.,CO.

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Primary Device ID04582276129471
NIH Device Record Key815ab4dc-6de2-4871-9da2-9b2c494d3024
Commercial Distribution StatusIn Commercial Distribution
Brand NameCROWN PX
Version Model NumberN41, W0.5
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
GS104582276129471 [Primary]
GS104582276129471 [Primary]
GS104582276129471 [Primary]
GS104582276129471 [Primary]
GS104582276129471 [Primary]
GS104582276129471 [Primary]
GS104582276129471 [Primary]
GS104582276129471 [Primary]
GS104582276129471 [Primary]
GS104582276129471 [Primary]
GS104582276129471 [Primary]
GS104582276129471 [Primary]
GS104582276129471 [Primary]
GS104582276129471 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELMDenture, Plastic, Teeth
ELMDenture, Plastic, Teeth
ELMDenture, Plastic, Teeth
ELMDenture, Plastic, Teeth
ELMDenture, Plastic, Teeth
ELMDenture, Plastic, Teeth
ELMDenture, Plastic, Teeth
ELMDenture, Plastic, Teeth
ELMDenture, Plastic, Teeth
ELMDenture, Plastic, Teeth
ELMDenture, Plastic, Teeth
ELMDenture, Plastic, Teeth
ELMDenture, Plastic, Teeth
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 Date2020-07-31
Device Publish Date2020-07-23

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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