NAVIFILE GOLD NITI FILES 6/pk .06 TAPER 21mm # 40 - NITI ROTARY FILES (6/pack) Taper: .06, Tip Size: - SCOTT'S DENTAL SUPPLY L.L.C.

Duns Number:137217043

Device Description: NITI ROTARY FILES (6/pack) Taper: .06, Tip Size: 40, Size: 21mm; For more information: htt NITI ROTARY FILES (6/pack) Taper: .06, Tip Size: 40, Size: 21mm; For more information: https://www.scottsdental.com/catalog/product/view/id/31804/s/navifile-gold-niti-rotary-files/

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More Product Details

Catalog Number

130-1640

Brand Name

NAVIFILE GOLD NITI FILES 6/pk .06 TAPER 21mm # 40

Version/Model Number

130-1640

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

EKS

Product Code Name

FILE, PULP CANAL, ENDODONTIC

Device Record Status

Public Device Record Key

03777877-e08e-42ed-87c4-a1ee4d7cbe92

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