Jensen FR Zirconia 40590

GUDID 00817340021790

JENSEN INDUSTRIES INC.

Dental appliance fabrication material, ceramic
Primary Device ID00817340021790
NIH Device Record Key7ed85676-abca-4a2a-8f08-9e8eac1d9236
Commercial Distribution StatusIn Commercial Distribution
Brand NameJensen FR Zirconia
Version Model NumberJensen FR Zr Unshaded 15.4mm Frame 6pk
Catalog Number40590
Company DUNS060018587
Company NameJENSEN INDUSTRIES INC.
Device Count6
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 Datetrue
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
GS100817340021790 [Primary]
GS100817340022575 [Unit of Use]

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 Date2016-09-23

Devices Manufactured by JENSEN INDUSTRIES INC.

00817340025996 - MiYO Esthetic System2023-08-03
00817340025989 - MiYO Esthetic System2023-08-02
00817340026009 - MiYO Esthetic System2023-03-30
00817340025972 - MiYO Esthetic System2023-03-07
00817340025941 - MiYO Esthetic System2023-02-20
00817340025958 - MiYO Esthetic System2023-02-16
00817340025965 - MiYO Esthetic System2023-02-16
00817340025903 - MiYO Esthetic System2022-09-02

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