Catalog Number

AU-BDS5100

Brand Name

Quolis 5000 Series Dental Unit

Version/Model Number

Quolis

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

-

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

K072273

Product Code

NRD

Product Code Name

Unit, Operative Dental, Accessories

Public Device Record Key

fc202d48-7843-4830-acf4-33cd3f02f6da

Public Version Date

May 27, 2022

Public Version Number

2

DI Record Publish Date

November 02, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-