SCOTT'S BIG-BITE HP SUPER-FAST SET - SCOTT'S DENTAL SUPPLY L.L.C.

Duns Number:137217043

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More Product Details

Catalog Number

104-9003

Brand Name

SCOTT'S BIG-BITE HP SUPER-FAST SET

Version/Model Number

104-9003

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

ELW

Product Code Name

Material, Impression

Device Record Status

Public Device Record Key

59f3d3ea-0e56-4a1f-864e-2cdfeb316145

Public Version Date

August 26, 2020

Public Version Number

4

DI Record Publish Date

February 13, 2017

Additional Identifiers

Package DI Number

D77810490031

Quantity per Package

2

Contains DI Package

D77810490030

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

KIT

"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