KATANA Cleaner

GUDID EKUR003971KA1

Trial

KURARAY NORITAKE DENTAL INC.

Dental restoration fixation cleaning solution

• Primary Device ID: EKUR003971KA1
• NIH Device Record Key: bd08967c-db9d-40af-b9a0-1381d602841e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KATANA Cleaner
• Version Model Number: #3971-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: 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	EKUR003971KA1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191133

FDA Product Code

• LBH: Varnish, Cavity

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: 2019-12-18
• Device Publish Date: 2019-12-10

On-Brand Devices [KATANA Cleaner ]

• EKUR003971KA1: Trial
• EKUR003970KA1: #3970-KA