Catalog Number

3823

Brand Name

BIO-C SEALER

Version/Model Number

BIO-C SEALER 2 g

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

K172701

Product Code

KIF

Product Code Name

Resin, Root Canal Filling

Public Device Record Key

258a376a-1eba-426d-8871-a877e4da52da

Public Version Date

November 13, 2020

Public Version Number

1

DI Record Publish Date

November 05, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-