Catalog Number

-

Brand Name

Candid Refinement Impression Kit

Version/Model Number

ITISK00001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K082560

Product Code

EHY

Product Code Name

Tray, Impression, Preformed

Public Device Record Key

5cb0dcfe-5ac3-428c-8728-a98073136078

Public Version Date

April 08, 2021

Public Version Number

1

DI Record Publish Date

March 31, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-