Catalog Number

86725

Brand Name

NobelProcera®

Version/Model Number

86725

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K153534

Product Code

ELL

Product Code Name

TEETH, PORCELAIN

Public Device Record Key

642013d0-7d61-4dfc-9386-b63435b4eac2

Public Version Date

December 21, 2020

Public Version Number

1

DI Record Publish Date

December 11, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-