Catalog Number

-

Brand Name

Midicone Abutment

Version/Model Number

DEMA40

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 03, 2019

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

K082843

Product Code

NHA

Product Code Name

Abutment, Implant, Dental, Endosseous

Public Device Record Key

d2310ad5-1af0-44ff-997e-292787cbbcea

Public Version Date

May 26, 2021

Public Version Number

8

DI Record Publish Date

August 07, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-