AccessGUDID - DEVICE: KATANA Cleaner (EKUR003971KA1)

GUDID

Device Identifier (DI) Information

Brand Name: KATANA Cleaner
Version or Model: #3971-KA
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: KURARAY NORITAKE DENTAL INC.

Primary DI Number: EKUR003971KA1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 697119498 *Terms of Use

Device Description: Trial

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LBH	Varnish, Cavity
PME	External Cleaning Solution

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K191133	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bd08967c-db9d-40af-b9a0-1381d602841e
Public Version Date: August 10, 2021
Public Version Number: 2
DI Record Publish Date: December 10, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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