DS PrimeTaper - PrimeTaper Drill 3 Ø2.95 9-11 GS - Dentsply Implants Manufacturing GmbH

Duns Number:344038836

Device Description: PrimeTaper Drill 3 Ø2.95 9-11 GS

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


More Product Details

Catalog Number

68017233

Brand Name

DS PrimeTaper

Version/Model Number

68017233

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

-

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

NDP

Product Code Name

Accessories, implant, dental, endosseous

Device Record Status

Public Device Record Key

1fcbf793-f7b9-40a4-891b-e5253b76e50c

Public Version Date

July 15, 2022

Public Version Number

1

DI Record Publish Date

July 07, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DENTSPLY IMPLANTS MANUFACTURING GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1379
2 A medical device with a moderate to high risk that requires special controls. 2266