Jensen ECO Zirconia 40906

GUDID 00817340021752

JENSEN INDUSTRIES INC.

Dental appliance fabrication material, ceramic
Primary Device ID00817340021752
NIH Device Record Key4bc40252-8ba7-4e88-a34d-c47d8708edda
Commercial Distribution StatusIn Commercial Distribution
Brand NameJensen ECO Zirconia
Version Model NumberJensen ECO Zr Unshaded 12mm Frame 2pk
Catalog Number40906
Company DUNS060018587
Company NameJENSEN INDUSTRIES INC.
Device Count2
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
GS100817340021752 [Primary]
GS100817340022537 [Unit of Use]

FDA Product Code

ELLTeeth, Porcelain

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-24
Device Publish Date2016-09-23

On-Brand Devices [Jensen ECO Zirconia]

00817340021783Jensen ECO Zr Unshaded 20mm Frame 2pk
00817340021776Jensen ECO Zr Unshaded 15.4mm Frame 2pk
00817340021769Jensen ECO Zr Unshaded 14mm Frame 2pk
00817340021752Jensen ECO Zr Unshaded 12mm Frame 2pk

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