Densah Bur - Densah Burs are indicated for use to prepare - VERSAH, LLC

Duns Number:081472844

Device Description: Densah Burs are indicated for use to prepare osteotomies for dental implant placement in t Densah Burs are indicated for use to prepare osteotomies for dental implant placement in the mandible and maxilla.

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


More Product Details

Catalog Number

-

Brand Name

Densah Bur

Version/Model Number

VT2838

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

EJL

Product Code Name

Bur, Dental

Device Record Status

Public Device Record Key

cadeb904-067a-413c-bca6-83d95aa43f98

Public Version Date

April 27, 2020

Public Version Number

1

DI Record Publish Date

April 17, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VERSAH, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 72