SELECT TEMPORARY FILLING MATERIAL 30 GM JAR - Scott’s Select Temporary Filling material is - SCOTT'S DENTAL SUPPLY L.L.C.

Duns Number:137217043

Device Description: Scott’s Select Temporary Filling material is indicated for the temporary filling of root c Scott’s Select Temporary Filling material is indicated for the temporary filling of root canal access opening, cavity preparations that require temporary fillings for short periods during therapeutic treatment and temporary filling for small inlay preparations. Scotts Select Temporary filling material is a single paste that can be applied by spatula. It sets with a slight expansion to a hard material that can be removed without the use of burs. It is a non-eugenol formulation allowing it to be applied in locations where a resin such as a composite restorative or bonding system will be used in the final restorative technique. Instructions for use and SDS available at https://www.scottsdental.com/temporary-filling-material-scott-s-select.html

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More Product Details

Catalog Number

199-1055

Brand Name

SELECT TEMPORARY FILLING MATERIAL 30 GM JAR

Version/Model Number

199-1055

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

EMA

Product Code Name

Cement, Dental

Device Record Status

Public Device Record Key

2697c4ed-50bc-487c-b74e-8fa25b4f62a2

Public Version Date

December 20, 2018

Public Version Number

4

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