Catalog Number

-

Brand Name

NexTemp Clear

Version/Model Number

3001473

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

K051866

Product Code

EMA

Product Code Name

Cement, Dental

Public Device Record Key

12306921-ae3e-4c1c-83e5-da712a5922e4

Public Version Date

November 25, 2020

Public Version Number

1

DI Record Publish Date

November 17, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-