KDF Zirconia Disc

GUDID 04560230233730

DENKEN-HIGHDENTAL CO., LTD.

Dental appliance fabrication material, ceramic
Primary Device ID04560230233730
NIH Device Record Key3633a8bf-5625-4d65-9609-b91ab6198249
Commercial Distribution StatusIn Commercial Distribution
Brand NameKDF Zirconia Disc
Version Model NumberMU-BL2/14mm
Company DUNS693815540
Company NameDENKEN-HIGHDENTAL CO., LTD.
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 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
GS104560230233730 [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 Date2023-06-26
Device Publish Date2023-06-16

On-Brand Devices [KDF Zirconia Disc]

04560230233808MU-BL2/35mm
04560230233792MU-BL2/30mm
04560230233785MU-BL2/25mm
04560230233778MU-BL2/22mm
04560230233761MU-BL2/20mm
04560230233754MU-BL2/18mm
04560230233747MU-BL2/16mm
04560230233730MU-BL2/14mm
04560230233723MU-BL2/10mm
04560230233983MU-A1/35mm
04560230233976MU-A1/30mm
04560230233969MU-A1/25mm
04560230233952MU-A1/22mm
04560230233945MU-A1/20mm
04560230233938MU-A1/18mm
04560230233921MU-A1/16mm
04560230233914MU-A1/14mm
04560230233907MU-A1/10mm
04560230234072MU-A2/35mm
04560230234065MU-A2/30mm
04560230234058MU-A2/25mm
04560230234041MU-A2/22mm
04560230234034MU-A2/20mm
04560230234027MU-A2/18mm
04560230234010MU-A2/16mm
04560230234003MU-A2/14mm
04560230233990MU-A2/10mm
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