CLEARFIL™ Universal Bond - Bottle Trial - KURARAY NORITAKE DENTAL INC.

Duns Number:697119498

Device Description: Bottle Trial

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More Product Details

Catalog Number

-

Brand Name

CLEARFIL™ Universal Bond

Version/Model Number

#3291-KA

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K132450

Product Code Details

Product Code

KLE

Product Code Name

Agent, Tooth Bonding, Resin

Device Record Status

Public Device Record Key

533fcd50-45d0-4818-974d-292a5f569d0c

Public Version Date

August 10, 2021

Public Version Number

4

DI Record Publish Date

February 17, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KURARAY NORITAKE DENTAL INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 3252