KATANA™ Zirconia Block

GUDID EKUR1256602KA0

STML 14Z L A2

KURARAY NORITAKE DENTAL INC.

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• Primary Device ID: EKUR1256602KA0
• NIH Device Record Key: ab091bfc-061d-4e57-922e-06698ae9d684
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KATANA™ Zirconia Block
• Version Model Number: 125-6602KA
• Company DUNS: 697119498
• Company Name: KURARAY NORITAKE DENTAL INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Height: 20.2 Millimeter
• Length: 40 Millimeter
• Width: 17.8 Millimeter
• Height: 20.2 Millimeter
• Length: 40 Millimeter
• Width: 17.8 Millimeter
• Height: 20.2 Millimeter
• Length: 40 Millimeter
• Width: 17.8 Millimeter
• Height: 20.2 Millimeter
• Length: 40 Millimeter
• Width: 17.8 Millimeter
• Height: 20.2 Millimeter
• Length: 40 Millimeter
• Width: 17.8 Millimeter
• Height: 20.2 Millimeter
• Length: 40 Millimeter
• Width: 17.8 Millimeter
• Height: 20.2 Millimeter
• Length: 40 Millimeter
• Width: 17.8 Millimeter
• Height: 20.2 Millimeter
• Length: 40 Millimeter
• Width: 17.8 Millimeter
• Height: 20.2 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EKUR1256602KA0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190436

FDA Product Code

• EIH: Powder, Porcelain

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-09
• Device Publish Date: 2019-07-01

On-Brand Devices [KATANA™ Zirconia Block]

• EKUR1256011KA0: ST 12Z CL
• EKUR1256000KA0: STML 12Z Introductory Set White
• EKUR1255990KA0: STML 12Z Introductory Set Natural
• EKUR1255980KA0: STML 12Z Basic Set
• EKUR1255972KA0: STML 14Z NW
• EKUR1255961KA0: STML 12Z NW
• EKUR1255952KA0: STML 14Z D3
• EKUR1255941KA0: STML 12Z D3
• EKUR1255932KA0: STML 14Z D2
• EKUR1255921KA0: STML 12Z D2
• EKUR1255912KA0: STML 14Z C3
• EKUR1255901KA0: STML 12Z C3
• EKUR1255892KA0: STML 14Z C2
• EKUR1255881KA0: STML 12Z C2
• EKUR1255872KA0: STML 14Z C1
• EKUR1255861KA0: STML 12Z C1
• EKUR1255852KA0: STML 14Z B3
• EKUR1255841KA0: STML 12Z B3
• EKUR1255832KA0: STML 14Z B2
• EKUR1255821KA0: STML 12Z B2
• EKUR1255812KA0: STML 14Z B1
• EKUR1255801KA0: STML 12Z B1
• EKUR1255792KA0: STML 14Z A4
• EKUR1255781KA0: STML 12Z A4
• EKUR1255772KA0: STML 14Z A3.5
• EKUR1255761KA0: STML 12Z A3.5
• EKUR1255752KA0: STML 14Z A3
• EKUR1255741KA0: STML 12Z A3
• EKUR1255732KA0: STML 14Z A2
• EKUR1255721KA0: STML 12Z A2
• EKUR1255712KA0: STML 14Z A1
• EKUR1255701KA0: STML 12Z A1
• EKUR1256722KA0: STML 14Z L NW
• EKUR1256712KA0: STML 14Z L D3
• EKUR1256702KA0: STML 14Z L D2
• EKUR1256692KA0: STML 14Z L C3
• EKUR1256682KA0: STML 14Z L C2
• EKUR1256672KA0: STML 14Z L C1
• EKUR1256662KA0: STML 14Z L B3
• EKUR1256652KA0: STML 14Z L B2
• EKUR1256642KA0: STML 14Z L B1
• EKUR1256632KA0: STML 14Z L A4
• EKUR1256622KA0: STML 14Z L A3.5
• EKUR1256612KA0: STML 14Z L A3
• EKUR1256602KA0: STML 14Z L A2
• EKUR1256592KA0: STML 14Z L A1