Catalog Number

-

Brand Name

Ceramill

Version/Model Number

NPAGCMN1.501000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

-

Product Code

ELJ

Product Code Name

TEETH, ARTIFICIAL, POSTERIOR WITH METAL INSERT

Public Device Record Key

39183ef0-894a-4004-ae42-9fe0d57e7df9

Public Version Date

October 29, 2021

Public Version Number

4

DI Record Publish Date

February 06, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-