Vintage ZR Press Over 8973

GUDID E23589730

VINTAGE ZR PRESS OVER A3.5

SHOFU DENTAL CORPORATION

Dental appliance fabrication material, ceramic
Primary Device IDE23589730
NIH Device Record Key307505f0-839a-43b7-ae2e-6d06c53fcdd0
Commercial Distribution StatusIn Commercial Distribution
Brand NameVintage ZR Press Over
Version Model Number8973
Catalog Number8973
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

Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE23589730 [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 Date2016-09-24

On-Brand Devices [Vintage ZR Press Over]

E23589870VINTAGE ZR PRESS OVER N
E23589860VINTAGER ZR PRESS OVER W3
E23589850VINTAGE ZR PRESS OVER W2
E23589840VINTAGER ZR PRESS OVER W1
E23589830VINTAGE ZR PRESS OVER D3
E23589820VINTAGE ZR PRESS OVER D2
E23589800VINTAGE ZR PRESS OVER C2
E23589790VINTAGE ZR PRESS OVER C1
E23589760VINTAGE ZR PRESS OVER B2
E23589750VINTAGE ZR PRESS OVER B1
E23589730VINTAGE ZR PRESS OVER A3.5
E23589720VINTAGE ZR PRESS OVER A3
E23589710VINTAGE ZR PRESS OVER A2
E23589700VINTAGE ZR PRESS OVER A1

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