IQ Dental - IQDENT PCA LIQUID 40ML - IQ DENTAL SUPPLY LLC

Duns Number:830702846

Device Description: IQDENT PCA LIQUID 40ML

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

IQ Dental

Version/Model Number

FP-IQDENT-067

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K902635

Product Code Details

Product Code

EMA

Product Code Name

Cement, Dental

Device Record Status

Public Device Record Key

5acd7db7-a155-4dc4-895e-37a0c7de1554

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 19, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IQ DENTAL SUPPLY LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 119