Catalog Number

100-UTD3500RS

Brand Name

DHPI Health-Tec Dental Amalgam Alloy

Version/Model Number

100-UTD3500RS

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 30, 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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K821222,K821222

Product Code

EJJ

Product Code Name

Alloy, Amalgam

Public Device Record Key

a9887f6f-5f4a-4b07-84b7-3f2a24bda339

Public Version Date

September 30, 2022

Public Version Number

3

DI Record Publish Date

January 24, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-