K-ETCHANT GEL

GUDID EKUR000013KA1

KURARAY NORITAKE DENTAL INC.

Dental etching solution

• Primary Device ID: EKUR000013KA1
• NIH Device Record Key: d0cbdd0e-9c1f-44aa-806a-81d5becc6857
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K-ETCHANT GEL
• Version Model Number: #013-KA
• 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	EKUR000013KA1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062409

FDA Product Code

• EBF: Material, Tooth Shade, Resin

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.

• 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