Ice Blue Tinted Monomer - Tinted Liquid - JBC and Company

Duns Number:080390783

Device Description: Tinted Liquid

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More Product Details

Catalog Number

R

Brand Name

Ice Blue Tinted Monomer

Version/Model Number

R

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

Yes

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

K974727

Product Code Details

Product Code

EBI

Product Code Name

Resin, Denture, Relining, Repairing, Rebasing

Device Record Status

Public Device Record Key

0c5bcbb8-b719-4c9f-9389-f96e1bbd720b

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

September 15, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"JBC AND COMPANY" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 168