Noritake Super Porcelain EX-3 ESTHETIC WHITE KIT

GUDID EKUR1020270KA0

102g

KURARAY NORITAKE DENTAL INC.

Dental appliance fabrication material, ceramic

• Primary Device ID: EKUR1020270KA0
• NIH Device Record Key: f77488dd-af83-451c-93ec-bee2acfb6551
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Noritake Super Porcelain EX-3 ESTHETIC WHITE KIT
• Version Model Number: 102-0270KA
• 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: true
• 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	EKUR1020270KA0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193060

FDA Product Code

• EIH: Powder, Porcelain

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-24
• Device Publish Date: 2017-02-17

Devices Manufactured by KURARAY NORITAKE DENTAL INC.

• EKUR001024KA1 - Applicator brush (fine): 2024-09-03
• EKUR001025KA0 - Applicator brush (endo): 2024-09-03
• EKUR001221KA0 - Applicator brush (superfine): 2024-09-03
• EKUR1259730KA0 - KATANA™ Zirconia ONE: 2024-04-08 SPEED CROWN A1
• EKUR1259731KA0 - KATANA™ Zirconia ONE: 2024-04-08 SPEED CROWN A2
• EKUR1259732KA0 - KATANA™ Zirconia ONE: 2024-04-08 SPEED CROWN A3
• EKUR1259733KA0 - KATANA™ Zirconia ONE: 2024-04-08 SPEED CROWN A3.5
• EKUR1259734KA0 - KATANA™ Zirconia ONE: 2024-04-08 SPEED CROWN A4