Catalog Number

9000830

Brand Name

Implant Prosthetics

Version/Model Number

9000830

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

K183518,K183518

Product Code

NHA

Product Code Name

Abutment, Implant, Dental, Endosseous

Public Device Record Key

ff1f4429-dbca-4750-9c00-27888a9627e6

Public Version Date

October 19, 2022

Public Version Number

2

DI Record Publish Date

September 06, 2022

Package DI Number

00842092165751

Quantity per Package

10

Contains DI Package

00842092165744

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-