Catalog Number

-

Brand Name

ELiTEDENT

Version/Model Number

PS-1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 23, 2021

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K040396

Product Code

ELC

Product Code Name

Scaler, Ultrasonic

Public Device Record Key

ad7a2830-9c6f-47ba-8167-54a1a77d71ee

Public Version Date

September 23, 2021

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-