Two Striper - Diamond Dental Bur - ABRASIVE TECHNOLOGY, INC.

Duns Number:054028295

Device Description: Diamond Dental Bur

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

CFKT02314

Brand Name

Two Striper

Version/Model Number

L254.10Z2 ZTECH PLUS

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)

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

DZP

Product Code Name

INSTRUMENT, DIAMOND, DENTAL

Device Record Status

Public Device Record Key

de0fcf3c-a5b3-4f70-8277-a8ea2157e101

Public Version Date

June 02, 2021

Public Version Number

1

DI Record Publish Date

May 25, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ABRASIVE TECHNOLOGY, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2300