Catalog Number

TFRK-S

Brand Name

Dental Engineering Lab-TFRK

Version/Model Number

TFRK-S

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

K122501

Product Code

ELC

Product Code Name

Scaler, Ultrasonic

Public Device Record Key

649f08fe-3fd5-46ab-8774-737533f24b44

Public Version Date

February 21, 2019

Public Version Number

2

DI Record Publish Date

October 08, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-