Catalog Number

52000320

Brand Name

Chrome-Cobalt-Bonding

Version/Model Number

52000320

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EBI

Product Code Name

RESIN, DENTURE, RELINING, REPAIRING, REBASING

Public Device Record Key

4cb85179-580d-4838-b81b-e3705c656f10

Public Version Date

November 10, 2021

Public Version Number

4

DI Record Publish Date

September 22, 2016

Package DI Number

EBRE520003209

Quantity per Package

1

Contains DI Package

EBRE520003200

Package Discontinue Date

September 22, 2016

Package Status

Not in Commercial Distribution

Package Type

dummy