SCOTT'S K-STYLE CROWN REMOVER w/ RUBBER TIPS - SCOTT'S K-STYLE CROWN REMOVER w/ RUBBER TIPS - SCOTT'S DENTAL SUPPLY L.L.C.

Duns Number:137217043

Device Description: SCOTT'S K-STYLE CROWN REMOVER w/ RUBBER TIPS

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More Product Details

Catalog Number

188-3103

Brand Name

SCOTT'S K-STYLE CROWN REMOVER w/ RUBBER TIPS

Version/Model Number

188-3103

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)

-

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

EIS

Product Code Name

REMOVER, CROWN

Device Record Status

Public Device Record Key

61031055-2093-486e-9695-ee9e6177941c

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

February 27, 2021

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