Catalog Number

101-0605

Brand Name

EsCom 100 B2 Capsules

Version/Model Number

101-0605

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

-

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

K110428,K110428,K110428

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Public Device Record Key

6a151cc3-6ab1-498f-a303-55cfb50b1fde

Public Version Date

January 26, 2021

Public Version Number

2

DI Record Publish Date

August 23, 2018

Package DI Number

20191004160150

Quantity per Package

20

Contains DI Package

08809262955590

Package Discontinue Date

January 25, 2021

Package Status

Not in Commercial Distribution

Package Type

-