KATANA™ Zirconia ONE

GUDID EKUR1259655KA0

BRIDGE D2

KURARAY NORITAKE DENTAL INC.

Dental appliance fabrication material, ceramic

• Primary Device ID: EKUR1259655KA0
• NIH Device Record Key: e32f3acb-6d25-4298-8f16-2d7199988fe8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KATANA™ Zirconia ONE
• Version Model Number: 125-9655KA
• 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

• Width: 17.8 Millimeter
• Height: 19.2 Millimeter
• Length: 40 Millimeter
• Width: 17.8 Millimeter
• Height: 19.2 Millimeter
• Length: 40 Millimeter
• Width: 17.8 Millimeter
• Height: 19.2 Millimeter
• Length: 40 Millimeter
• Width: 17.8 Millimeter
• Height: 19.2 Millimeter
• Length: 40 Millimeter
• Width: 17.8 Millimeter
• Height: 19.2 Millimeter
• Length: 40 Millimeter
• Width: 17.8 Millimeter
• Height: 19.2 Millimeter
• Length: 40 Millimeter
• Width: 17.8 Millimeter
• Height: 19.2 Millimeter
• Length: 40 Millimeter
• Width: 17.8 Millimeter
• Height: 19.2 Millimeter
• Length: 40 Millimeter
• Width: 17.8 Millimeter
• Height: 19.2 Millimeter
• Length: 40 Millimeter
• Width: 17.8 Millimeter
• Height: 19.2 Millimeter
• Length: 40 Millimeter
• Width: 17.8 Millimeter
• Height: 19.2 Millimeter
• Length: 40 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EKUR1259655KA0 [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: 2022-08-09
• Device Publish Date: 2022-08-01

On-Brand Devices [KATANA™ Zirconia ONE]

• EKUR1259658KA0: ASSORTMENT
• EKUR1259657KA0: BRIDGE NW
• EKUR1259656KA0: BRIDGE D3
• EKUR1259655KA0: BRIDGE D2
• EKUR1259654KA0: BRIDGE C3
• EKUR1259653KA0: BRIDGE C2
• EKUR1259652KA0: BRIDGE C1
• EKUR1259651KA0: BRIDGE B3
• EKUR1259650KA0: BRIDGE B2
• EKUR1259649KA0: BRIDGE B1
• EKUR1259648KA0: BRIDGE A4
• EKUR1259647KA0: BRIDGE A3.5
• EKUR1259646KA0: BRIDGE A3
• EKUR1259645KA0: BRIDGE A2
• EKUR1259644KA0: BRIDGE A1
• EKUR1259643KA0: CROWN NW
• EKUR1259642KA0: CROWN D3
• EKUR1259641KA0: CROWN D2
• EKUR1259640KA0: CROWN C3
• EKUR1259639KA0: CROWN C2
• EKUR1259638KA0: CROWN C1
• EKUR1259637KA0: CROWN B3
• EKUR1259636KA0: CROWN B2
• EKUR1259635KA0: CROWN B1
• EKUR1259634KA0: CROWN A4
• EKUR1259633KA0: CROWN A3.5
• EKUR1259632KA0: CROWN A3
• EKUR1259631KA0: CROWN A2
• EKUR1259630KA0: CROWN A1
• EKUR1259744KA0: SPEED CROWN ASSORTMENT
• EKUR1259743KA0: SPEED CROWN NW
• EKUR1259742KA0: SPEED CROWN D3
• EKUR1259741KA0: SPEED CROWN D2
• EKUR1259740KA0: SPEED CROWN C3
• EKUR1259739KA0: SPEED CROWN C2
• EKUR1259738KA0: SPEED CROWN C1
• EKUR1259737KA0: SPEED CROWN B3
• EKUR1259736KA0: SPEED CROWN B2
• EKUR1259735KA0: SPEED CROWN B1
• EKUR1259734KA0: SPEED CROWN A4
• EKUR1259733KA0: SPEED CROWN A3.5
• EKUR1259732KA0: SPEED CROWN A3
• EKUR1259731KA0: SPEED CROWN A2
• EKUR1259730KA0: SPEED CROWN A1
• EKUR1259699KA0: For IMPLANT L NW
• EKUR1259698KA0: For IMPLANT L D2
• EKUR1259697KA0: For IMPLANT L C2
• EKUR1259696KA0: For IMPLANT L C1
• EKUR1259695KA0: For IMPLANT L B2
• EKUR1259694KA0: For IMPLANT L B1