Catalog Number

-

Brand Name

BEGO VarseoSmile Crown Plus A1 250g

Version/Model Number

71191

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 29, 2022

Issuing Agency

In HIBCC

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K201668

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Public Device Record Key

520aa91a-4711-45a5-bac8-d86fb712dc53

Public Version Date

September 30, 2022

Public Version Number

2

DI Record Publish Date

August 27, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-