Catalog Number

1.501

Brand Name

Rodo Abutment Accessories

Version/Model Number

1.501

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 19, 2017

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

K160786

Product Code

NHA

Product Code Name

ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Public Device Record Key

132a2b2f-d59e-4756-bdf6-f0b3f65afd6d

Public Version Date

November 08, 2019

Public Version Number

5

DI Record Publish Date

September 18, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-