Catalog Number

301179

Brand Name

Nobel Biocare N1™

Version/Model Number

301179

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

QRQ

Product Code Name

Non-irrigation endosseous dental implant drill bits

Public Device Record Key

0ec6a597-7a1a-43f7-8ead-a307a1d767b9

Public Version Date

September 16, 2022

Public Version Number

2

DI Record Publish Date

May 06, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-