Catalog Number

S20 K

Brand Name

SMARTmatic S20 K

Version/Model Number

1.011.6751

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

b5d37bc1-d117-4975-80bf-39d7f2f9d0c3

Public Version Date

November 08, 2021

Public Version Number

2

DI Record Publish Date

March 01, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-