Catalog Number

B-3211

Brand Name

Bis-Silane

Version/Model Number

B-3211

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 02, 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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K874557

Product Code

EBC

Product Code Name

SEALANT, PIT AND FISSURE, AND CONDITIONER

Public Device Record Key

a56f6a66-8882-4e13-8d14-7bfa6b6c3095

Public Version Date

August 03, 2022

Public Version Number

6

DI Record Publish Date

June 12, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-