Catalog Number

System (USA)

Brand Name

COMFORTdrive System (USA)

Version/Model Number

1.005.5000

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

K080677

Product Code

EIA

Product Code Name

UNIT, OPERATIVE DENTAL

Public Device Record Key

885715e1-79b8-45db-8078-80ada2df93c7

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

September 26, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-