Catalog Number

80064

Brand Name

NobelProcera®

Version/Model Number

80064

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 20, 2021

Issuing Agency

In GS1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K162043

Product Code

ELL

Product Code Name

TEETH, PORCELAIN

Public Device Record Key

677565f7-73b7-48d4-9c45-161b5c539838

Public Version Date

May 20, 2022

Public Version Number

8

DI Record Publish Date

March 17, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-