Jensen XT Zirconia 55019

GUDID 00817340024098

JENSEN INDUSTRIES INC.

Dental appliance fabrication material, ceramic
Primary Device ID00817340024098
NIH Device Record Key8d889c4a-98d5-440d-8130-4c46d42e0730
Commercial Distribution StatusIn Commercial Distribution
Brand NameJensen XT Zirconia
Version Model NumberJensen XT TRAN Zr Mono A2 14mm Frame 2pk
Catalog Number55019
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
GS100817340023589 [Primary]
GS100817340024098 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-12
Device Publish Date2020-05-04

On-Brand Devices [Jensen XT Zirconia]

00817340023305Jensen XT Zr C3 98x18mm Disc
00817340023299Jensen XT Zr B2 98x18mm Disc
00817340021745Jensen XT Zr A3.5 98x18mm Disc
00817340021738Jensen XT Zr OM3 98x14mm Disc
00817340021721Jensen XT Zr OM2 98x14mm Disc
00817340021714Jensen XT Zr OM1 98x14mm Disc
00817340021707Jensen XT Zr D4 98x14mm Disc
00817340021691Jensen XT Zr D3 98x14mm Disc
00817340021684Jensen XT Zr C4 98x14mm Disc
00817340021677Jensen XT Zr C3 98x14mm Disc
00817340021660Jensen XT Zr C1 98x14mm Disc
00817340021653Jensen XT Zr B4 98x14mm Disc
00817340021646Jensen XT Zr B3 98x14mm Disc
00817340021639Jensen XT Zr B2 98x14mm Disc
00817340021622Jensen XT Zr A4 98x14mm Disc
00817340021615Jensen XT Zr A3.5 98x14mm Disc
00817340021608Jensen XT Zr Unshaded 98x18mm Disc
00817340021592Jensen XT Zr Unshaded 98x14mm Disc
00817340021585Jensen XT Zr Unshaded 98x12mm Disc
00817340021578Jensen XT Zr Unshaded 98x10mm Disc
00817340021561Jensen XT Zr Unshaded 15.4mm Frame 2pk
00817340021554Jensen XT Zr Unshaded 14mm Frame 2pk
00817340021547Jensen XT Zr Unshaded 24.5mm Frame 2pk
00817340021530Jensen XT Zr Unshaded 12mm Frame 2pk
00817340021523Jensen XT Zr D2 20mm Frames 2pk
00817340021516Jensen XT Zr C2 20mm Frames 2pk
00817340021509Jensen XT Zr B1 20mm Frames 2pk
00817340021493Jensen XT Zr D2 98x18mm Disc
00817340021486Jensen XT Zr C2 98x18mm Disc
00817340021479Jensen XT Zr B1 98x18mm Disc
00817340021462Jensen XT Zr D2 98x12mm Disc
00817340021455Jensen XT Zr C2 98x12mm Disc
00817340021448Jensen XT Zr B1 98x12mm Disc
00817340021431Jensen XT Zr D2 12mm Frames 2pk
00817340021424Jensen XT Zr B1 12mm Frames 2pk
00817340021417Jensen XT Zr C2 12mm Frames 2pk
00817340021400Jensen XT Zr A3 98x18mm Disc
00817340021394Jensen XT Zr A2 98x18mm Disc
00817340021387Jensen XT Zr A1 98x18mm Disc
00817340021370Jensen XT Zr D2 98x14mm Disc
00817340021363Jensen XT Zr C2 98x14mm Disc
00817340021356Jensen XT Zr B1 98x14mm Disc
00817340021349Jensen XT Zr A3 98x14mm Disc
00817340021332Jensen XT Zr A2 98x14mm Disc
00817340021325Jensen XT Zr A1 98x14mm Disc
00817340021318Jensen XT Zr A3 98x12mm Disc
00817340021301Jensen XT Zr A2 98x12mm Disc
00817340021295Jensen XT Zr A1 98x12mm Disc
00817340021288Jensen XT Zr Unshaded 20mm Frames 2pk
00817340021271Jensen XT Zr A3 20mm Frames 2pk
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