K-Reamers - Endodontic instrument for professional dental use - MICRO MEGA

Duns Number:276075371

Device Description: Endodontic instrument for professional dental use only

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More Product Details

Catalog Number

60029712

Brand Name

K-Reamers

Version/Model Number

N130 L25

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

EKP

Product Code Name

Reamer, Pulp Canal, Endodontic

Device Record Status

Public Device Record Key

77c9be6f-956e-4255-904e-fe715bcae2cb

Public Version Date

December 29, 2020

Public Version Number

1

DI Record Publish Date

December 21, 2020

Additional Identifiers

Package DI Number

J015600297129

Quantity per Package

10

Contains DI Package

J015600297121

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"MICRO MEGA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 64
2 A medical device with a moderate to high risk that requires special controls. 2