Catalog Number

H-35010P

Brand Name

TheraBase Ca

Version/Model Number

H-35010P

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 11, 2022

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

K192007

Product Code

EMA

Product Code Name

Cement, Dental

Public Device Record Key

c2f2c2d9-018b-4566-ac90-44fb16bf4e39

Public Version Date

October 12, 2022

Public Version Number

3

DI Record Publish Date

November 06, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-