SELECT BPA FREE PIT & FISSURE SEALANT KIT OPAQUE - Scott's Select BPA-Free Pit & Fissure Sealant kit - SCOTT'S DENTAL SUPPLY L.L.C.

Duns Number:137217043

Device Description: Scott's Select BPA-Free Pit & Fissure Sealant kit is indicated for the covering and sealin Scott's Select BPA-Free Pit & Fissure Sealant kit is indicated for the covering and sealing of pits and fissures in the occlusal surfaces of posterior teeth to aid in the resistance to caries in those surfaces.BPA-Free Pit & Fissure Sealant is a light-cure pit and fissure sealant. It is a very low viscosity resin system with a white opaque color to help identify it's retention at recall appointments. It is contained in a direct delivery syringe system for quick and easy application.It is a diluted HDDMA-UDMA based resin with a white opaquer, a micro-fine silica particle and a photosensitive catalyst system. The Kit contains 4 x 1Gm Syringes of Sealant, 1 3mL bottle of Etchant and 10 applicator tips.Instructions for use and SDS available at https://www.scottsdental.com/pit-fissure-sealant-bpa-free.html

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More Product Details

Catalog Number

199-6010

Brand Name

SELECT BPA FREE PIT & FISSURE SEALANT KIT OPAQUE

Version/Model Number

199-6010

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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

-

Product Code Details

Product Code

EBC

Product Code Name

Sealant, Pit And Fissure, And Conditioner

Device Record Status

Public Device Record Key

1ebda5ff-1591-454b-bcba-79da9b09ee72

Public Version Date

December 19, 2018

Public Version Number

3

DI Record Publish Date

May 04, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SCOTT'S DENTAL SUPPLY L.L.C." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1050
2 A medical device with a moderate to high risk that requires special controls. 90