Catalog Number

-

Brand Name

IQ Dental

Version/Model Number

NRGAISR

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

K041028

Product Code

ELW

Product Code Name

Material, Impression

Public Device Record Key

e0184d5c-d42e-41cb-b90f-25d971e66561

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 25, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-