Catalog Number

MDL2518SZ

Brand Name

BioHorizons

Version/Model Number

MDL2518SZ

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

K070601

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Public Device Record Key

3022ef49-9858-4ab4-abb3-ce42b48e5a10

Public Version Date

January 04, 2022

Public Version Number

1

DI Record Publish Date

December 27, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-