Catalog Number

2081209

Brand Name

Ney®

Version/Model Number

Gold Color Denture Clasp

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 23, 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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EJT

Product Code Name

ALLOY, GOLD-BASED NOBLE METAL

Public Device Record Key

ab5f5464-1f9b-448b-9217-6ad8877346b8

Public Version Date

May 24, 2022

Public Version Number

4

DI Record Publish Date

January 31, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-