Imagine Zirconia MI012

GUDID 00817340025101

JENSEN INDUSTRIES INC.

Dental appliance fabrication material, ceramic
Primary Device ID00817340025101
NIH Device Record Key29a14f14-50e8-42d3-8d04-43cd1cd5b440
Commercial Distribution StatusIn Commercial Distribution
Brand NameImagine Zirconia
Version Model NumberImagine Enamel Liquid 15ml
Catalog NumberMI012
Company DUNS060018587
Company NameJENSEN INDUSTRIES INC.
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100817340025101 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-28
Device Publish Date2020-10-20

On-Brand Devices [Imagine Zirconia]

00817340023206Imagine Zr Multilayered B3 98x14mm Disc
00817340023190Imagine Zr Multilayered B2 98x14mm Disc
00817340023183Imagine Zr Multilayered B1 98x14mm Disc
00817340023176Imagine Zr Multilayered A3.5 98x14mm Disc
00817340023169Imagine Zr Multilayered A4 98x14mm Disc
00817340023152Imagine Zr Multilayered A3 98x14mm Disc
00817340023145Imagine Zr Multilayered A2 98x14mm Disc
00817340023138Imagine Zr Multilayered A1 98x14mm Disc
00817340022285Imagine Micro Layering Kit
00817340022278Imagine Zr Unshaded 98x22mm Disc
00817340022261Imagine Zr Unshaded 98x12mm Disc
00817340022254Imagine Zr Unshaded 18mm Frame 2pk
00817340022247Imagine Zr Unshaded 14mm Frame 2pk
00817340022230Imagine Zr Unshaded 98x18mm Disc
00817340022223Imagine Zr Unshaded 98x14mm Disc
00817340025637Imagine Zr Multilayered BL 98x14mm Disc
00817340025620Imagine Zr Multilayered D4 98x14mm Disc
00817340025613Imagine Zr Multilayered D3 98x14mm Disc
00817340025606Imagine Zr Multilayered D2 98x14mm Disc
00817340025590Imagine Zr Multilayered C4 98x14mm Disc
00817340025583Imagine Zr Multilayered C3 98x14mm Disc
00817340025576Imagine Zr Multilayered C2 98x14mm Disc
00817340025569Imagine Zr Multilayered C1 98x14mm Disc
00817340025552Imagine Zr Multilayered B4 98x14mm Disc
00817340023282Imagine Zr Multilayered B3 98x18mm Disc
00817340023275Imagine Zr Multilayered B2 98x18mm Disc
00817340023268Imagine Zr Multilayered B1 98x18mm Disc
00817340023251Imagine Zr Multilayered A3.5 98x18mm Disc
00817340023244Imagine Zr Multilayered A4 98x18mm Disc
00817340023237Imagine Zr Multilayered A3 98x18mm Disc
00817340023220Imagine Zr Multilayered A2 98x18mm Disc
00817340023213Imagine Zr Multilayered A1 98x18mm Disc
00817340025101Imagine Enamel Liquid 15ml
00817340025095Imagine X TRAN Zr A1 98x22 Disc
00817340024579Imagine X TRAN Zr D4 98x14 Disc
00817340024555Imagine X TRAN Zr D2 98x14 Disc
00817340024548Imagine X TRAN Zr C4 98x14 Disc
00817340024531Imagine X TRAN Zr C3 98x14 Disc
00817340024524Imagine X TRAN Zr C2 98x14 Disc
00817340024517Imagine X TRAN Zr C1 98x14 Disc
00817340024500Imagine X TRAN Zr B4 98x14 Disc
00817340024494Imagine X TRAN Zr B3 98x14 Disc
00817340024487Imagine X TRAN Zr B2 98x14 Disc
00817340024470Imagine X TRAN Zr B1 98x14 Disc
00817340024463Imagine X TRAN Zr A4 98x14 Disc
00817340024456Imagine X TRAN Zr A3.5 98x14 Disc
00817340024449Imagine X TRAN Zr A3 98x14 Disc
00817340024432Imagine X TRAN Zr A2 98x14 Disc
00817340024425Imagine X TRAN Zr A1 98x14 Disc
00817340025767Imagine Enamel Liquid 2 15ml

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