Catalog Number

-

Brand Name

Park Dental Research Corp.

Version/Model Number

2015-CO

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K121707

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Public Device Record Key

f4781332-e951-45f3-9801-837df5d7ede7

Public Version Date

November 14, 2018

Public Version Number

4

DI Record Publish Date

September 16, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-