Catalog Number

AE650

Brand Name

Diamodent

Version/Model Number

N/A

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

-

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Public Device Record Key

4518bbe2-f879-4168-aeee-cf6f48346fb6

Public Version Date

September 22, 2020

Public Version Number

2

DI Record Publish Date

January 04, 2019

Package DI Number

D907AE6501

Quantity per Package

6

Contains DI Package

D907AE6500

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pouch