Catalog Number

-

Brand Name

Xelis Dental 2.0

Version/Model Number

Xelis Dental 2.0

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

K193369

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Public Device Record Key

13b02048-7f22-4fca-81ba-7316ff438c78

Public Version Date

November 26, 2021

Public Version Number

1

DI Record Publish Date

November 18, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-