Vintage Halo 7395

GUDID E23573950

HALO EFFECT COLOR 50G OM-YELLOW

SHOFU DENTAL CORPORATION

Dental appliance fabrication material, ceramic
Primary Device IDE23573950
NIH Device Record Key6a884184-016c-40e4-987a-81ac24cd690e
Commercial Distribution StatusIn Commercial Distribution
Brand NameVintage Halo
Version Model Number7395
Catalog Number7395
Company DUNS054618202
Company NameSHOFU DENTAL CORPORATION
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone760-566-3528
Emailckaemmerlen@shofu.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE23573950 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EIHPowder, Porcelain

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-24
Device Publish Date2016-09-25

On-Brand Devices [Vintage Halo]

E23579020HALO VALUE MINUS 15G VMODROOTR
E23579010HALO VALUE MINUS 15G VMOD-R4
E23579000HALO VALUE MINUS 15G VMOD-R3.5
E23578990HALO VALUE MINUS 15G VMOD-R3
E23578980HALO VALUE MINUS 15G VMOD-R2
E23578970HALO VALUE MINUS 15G VMOD-R1
E23578960HALO VALUE MINUS 15G VMODROOTA
E23578950HALO VALUE MINUS 15G VMOD-A4
E23578940HALO VALUE MINUS 15G VMOD-A3.5
E23578930HALO VALUE MINUS 15G VMOD-A3
E23578920HALO VALUE MINUS 15G VMOD-A2
E23578910HALO VALUE MINUS 15G VMOD-A1
E23578820VM ROOT R BODY 15g
E23578810HALO VALUE MINUS 15G VMR4B
E23578800HALO VALUE MINUS 15G VMR3.5B
E23578790HALO VALUE MINUS 15G VMR3B
E23578780HALO VALUE MINUS 15G VMR2B
E23578770HALO VALUE MINUS 15G VMR1B
E23578760HALO VALUE MINUS 15G VMROOTAB
E23578750HALO VALUE MINUS 15G VMA4B
E23578740HALO VALUE MINUS 15G VMA3.5B
E23578730HALO VALUE MINUS 15G VMA3B
E23578720HALO VALUE MINUS 15G VMA2B
E23578710HALO VALUE MINUS 15G VMA1B
E23578620HALO VALUE MINUS 15G VMR R0
E23578610HALO VALUE MINUS 15G VMR4O
E23578600HALO VALUE MINUS 15G VMR3.5O
E23578590HALO VALUE MINUS 15G VMR3O
E23578580HALO VALUE MINUS 15G VMR2O
E23578570HALO VALUE MINUS 15G VMR1O
E23578560HALO VALUE MINUS 15G VMROOTAO
E23578550HALO VALUE MINUS 15G VMA4O
E23578540HALO VALUE MINUS 15G VMA3.5O
E23578530HALO VALUE MINUS 15G VMA3O
E23578520HALO VALUE MINUS 15G VMA20
E23578510HALO VALUE MINUS 15G VMA1O
E23577880Vintage Halo Whitening 50g W3B
E23577870Vintage Halo Whitening 50g W2B
E23577860Vintage Halo Whitening 50g W1B
E23577830Vintage Halo Whitening 15g W3B
E23577820Vintage Halo Whitening 15g W2B
E23577810Vintage Halo Whitening 15g W1B
E23577780Vintage Halo Whitening 50g W30
E23577770Vintage Halo Whitening 50g W20
E23577760Vintage Halo Whitening 50g W10
E23577730Vintage Halo Whitening 15g W30
E23577720Vintage Halo Whitening 15g W20
E23577710Vintage Halo Whitening 15g W10
E23577700Vintage Halo Whitening Set
E23577490HALO OPAQUE DENTIN 50G OD-D4

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