Catalog Number

13621-022

Brand Name

Lares Research

Version/Model Number

757 ProStyle SF Lite 4H L

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

K141221

Product Code

EFB

Product Code Name

Handpiece, Air-Powered, Dental

Public Device Record Key

42df5b53-176c-4f74-83fd-0dc09916b12c

Public Version Date

November 09, 2020

Public Version Number

1

DI Record Publish Date

October 30, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-