Catalog Number

BONNT

Brand Name

Bonita Pit and Fissure Sealant

Version/Model Number

1.2 mL Natural Translucent

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K071158,K071158

Product Code

EBC

Product Code Name

Sealant, Pit And Fissure, And Conditioner

Public Device Record Key

d9c4e7bc-da08-46ab-8244-968831dd1864

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 05, 2016

Package DI Number

D820BONNT1

Quantity per Package

4

Contains DI Package

D820BONNT0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-