KATANA Cleaner

Basic Information

• Brand Name: KATANA Cleaner
• Primary DI: EKUR003971KA1
• Version / Model: #3971-KA
• Company Name: KURARAY NORITAKE DENTAL INC.
• Labeler DUNS: 697119498
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-10
• Public Version: 2
• Public Version Date: 2021-08-10
• Public Version Status: Update
• Public Device Record Key: bd08967c-db9d-40af-b9a0-1381d602841e

Device Description

Trial

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LBH	Varnish, Cavity	Dental	872.3260	2
PME	External Cleaning Solution	Dental	872.3260	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62929	Dental restoration fixation cleaning solution	A non-sterile liquid substance intended to be used to extra-orally clean the adherent surface of a dental restorative/prosthetic device (e.g., veneer, crown, inlay, onlay), after it has been assessed in situ as a trial, to improve adhesion when it is permanently fixed in place. The solution is typically a water-based gel containing potassium hydroxide supplied in a syringe with a number of applicator tips. It is not intended to be used as a tooth etching solution. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	EKUR003971KA1	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K191133	000