Catalog Number

330-DHPGPFM

Brand Name

Health-Tec/DHP Gutta Percha Points

Version/Model Number

330-DHPGPFM

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)

Yes

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

-

Product Code

EKM

Product Code Name

Gutta-Percha

Public Device Record Key

46449551-da05-4c23-872a-33aeee3332bc

Public Version Date

October 19, 2022

Public Version Number

1

DI Record Publish Date

October 11, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-