Catalog Number

AA201

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

-

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

9bb9193f-7d44-4ed7-b91e-9242a54a916d

Public Version Date

November 08, 2019

Public Version Number

2

DI Record Publish Date

December 21, 2018

Package DI Number

D907AA2012

Quantity per Package

12

Contains DI Package

D907AA2010

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pouch