SCOTT'S SELECT ALLOY 50/jar 2 SPILL - SCOTT'S DENTAL SUPPLY L.L.C.

Duns Number:137217043

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More Product Details

Catalog Number

106-1502

Brand Name

SCOTT'S SELECT ALLOY 50/jar 2 SPILL

Version/Model Number

106-1502

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K140125,K140125

Product Code Details

Product Code

EJJ

Product Code Name

Alloy, Amalgam

Device Record Status

Public Device Record Key

5973dd0c-8c4a-4061-ad58-8cf474ec27a2

Public Version Date

August 26, 2020

Public Version Number

4

DI Record Publish Date

May 25, 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