Catalog Number

-

Brand Name

JUVORA™ Natural Dental Disc

Version/Model Number

540112

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

K132725,K160918

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Public Device Record Key

42876330-acf0-47df-b425-cb567b86fb25

Public Version Date

June 21, 2022

Public Version Number

3

DI Record Publish Date

January 21, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-