Catalog Number

-

Brand Name

DenteShield Pit and Fissure Sealant Kit with Fluoride Opaque

Version/Model Number

685PITFTO

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"

Yes

For Single-Use

Yes

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

K093059

Product Code

EBC

Product Code Name

Sealant, Pit And Fissure, And Conditioner

Public Device Record Key

820ebebc-c84c-4445-b471-a15da666f07a

Public Version Date

April 09, 2020

Public Version Number

1

DI Record Publish Date

April 01, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-