MAXCUT CARBIDE BUR (100/pk) RA 8 - MAXCUT CARBIDE BUR (100/pk) Shape: Round; Size: - SCOTT'S DENTAL SUPPLY L.L.C.

Duns Number:137217043

Device Description: MAXCUT CARBIDE BUR (100/pk) Shape: Round; Size: 8; Shank: Latch; For more information: htt MAXCUT CARBIDE BUR (100/pk) Shape: Round; Size: 8; Shank: Latch; For more information: https://www.scottsdental.com/catalog/product/view/id/17301/s/ra-latch-carbide-burs-maxcut/

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More Product Details

Catalog Number

111-1978

Brand Name

MAXCUT CARBIDE BUR (100/pk) RA 8

Version/Model Number

111-1978

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

-

Product Code Details

Product Code

EJL

Product Code Name

BUR, DENTAL

Device Record Status

Public Device Record Key

b9b63b69-2a06-41e3-8948-db3265fb35e7

Public Version Date

March 08, 2021

Public Version Number

1

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