CARIES DETECTOR

GUDID EKUR000220KA1

KURARAY NORITAKE DENTAL INC.

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.

• EKUR1259852KA0 - KATANA™ Zirconia: 2026-03-09 YML T14 EW0 C
• EKUR1259863KA0 - KATANA™ Zirconia: 2026-03-09 YML T18 EW0 C
• EKUR1259874KA0 - KATANA™ Zirconia: 2026-03-09 YML T22 EW0 C
• EKUR1259882KA0 - KATANA™ Zirconia: 2026-03-09 YML T14 EW C
• EKUR1259893KA0 - KATANA™ Zirconia: 2026-03-09 YML T18 EW C
• EKUR1259904KA0 - KATANA™ Zirconia: 2026-03-09 YML T22 EW C
• EKUR1259915KA0 - KATANA™ Zirconia: 2026-03-09 YML T26 EW C
• EKUR1259755KA0 - KATANA™ Zirconia: 2025-09-09 YML T26 A1 C