Catalog Number

-

Brand Name

BioHorizons

Version/Model Number

3507D3

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

K030463

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Public Device Record Key

586a17fe-d404-4046-9ae8-36dad7a7da4a

Public Version Date

April 02, 2019

Public Version Number

3

DI Record Publish Date

September 11, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-