Catalog Number

ISI 5008 OB

Brand Name

One Piece O-Ball Dental Implant

Version/Model Number

O-Ball

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

DZE

Product Code Name

Implant, Endosseous, Root-Form

Public Device Record Key

ab28d831-e6c7-4f13-b267-6939c6aa3366

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

March 14, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-