Catalog Number

8:1

Brand Name

Elements 8:1

Version/Model Number

1.011.6786

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

K163239

Product Code

EFA

Product Code Name

Handpiece, belt and/or gear driven, dental

Public Device Record Key

4f5300a5-e527-45e6-8792-f8c23cf0b5fa

Public Version Date

November 08, 2021

Public Version Number

3

DI Record Publish Date

March 05, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-