CARIES DETECTOR

GUDID EKUR000220KA1

KURARAY NORITAKE DENTAL INC.

Dental caries detecting stain Dental caries detecting stain Dental caries detecting stain Dental caries detecting stain Dental caries detecting stain Dental caries detecting stain Dental caries detecting stain Dental caries detecting stain Dental caries detecting stain

• Primary Device ID: EKUR000220KA1
• NIH Device Record Key: f3d1f601-d8f3-4f1d-9efa-5864052c50be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CARIES DETECTOR
• Version Model Number: #220-KA
• Company DUNS: 697119498
• Company Name: KURARAY NORITAKE DENTAL INC.
• Device Count: 2
• 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	EKUR000220KA0 [Unit of Use]
HIBCC	EKUR000220KA1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012733

FDA Product Code

• LFC: Device, Caries Detection

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: 2018-07-06
• Device Publish Date: 2017-02-17

Devices Manufactured by KURARAY NORITAKE DENTAL INC.

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• 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
• EKUR1259735KA0 - KATANA™ Zirconia ONE: 2024-04-08 SPEED CROWN B1
• EKUR1259736KA0 - KATANA™ Zirconia ONE: 2024-04-08 SPEED CROWN B2
• EKUR1259737KA0 - KATANA™ Zirconia ONE: 2024-04-08 SPEED CROWN B3