Catalog Number

623802

Brand Name

Dycal® Dentin Radiopaque Calcium Hydroxide Composition

Version/Model Number

623802

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K780384,K780384

Product Code

EJK

Product Code Name

LINER, CAVITY, CALCIUM HYDROXIDE

Public Device Record Key

0e001961-1a29-48c1-9dff-adc6dc9f3cf8

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

D00262380262

Quantity per Package

6

Contains DI Package

D0026238021

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box