Catalog Number

-

Brand Name

JUVORA™ Dental Disc

Version/Model Number

540015

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 02, 2022

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

38e16d11-d41b-4045-ac72-d9119e2a6c37

Public Version Date

June 21, 2022

Public Version Number

2

DI Record Publish Date

June 14, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-