Catalog Number

SM375016

Brand Name

IQ Implants

Version/Model Number

SM375016

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

K130829

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Public Device Record Key

1280907a-0ed3-4ea7-9003-e28f76f09c71

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 25, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-