Catalog Number

AU-XV2510C

Brand Name

Belmont X-Calibur Unit

Version/Model Number

Belmont X-Calibur Unit

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

K000799

Product Code

EIA

Product Code Name

Unit, Operative Dental

Public Device Record Key

ad6c3f93-c8ce-486a-b9f4-f2cd0ee07628

Public Version Date

May 27, 2022

Public Version Number

2

DI Record Publish Date

November 20, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-