Catalog Number

1000-88

Brand Name

Ball Abutment Housing & Liner

Version/Model Number

1000-88

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

NDP

Product Code Name

Accessories, Implant, Dental, Endosseous

Public Device Record Key

c237e5b2-9bc5-4db8-8504-b8b6d077e3e6

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

December 29, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-