Catalog Number

-

Brand Name

X-CUBE

Version/Model Number

ACL(B)-45I

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"

Yes

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K092412

Product Code

EFA

Product Code Name

Handpiece, Belt And/Or Gear Driven, Dental

Public Device Record Key

c0a29c67-b86b-4932-a6c9-1c275fa9d3cf

Public Version Date

January 30, 2020

Public Version Number

1

DI Record Publish Date

January 22, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-