NanoPaq Flow C 3, 2 g - NanoPaq Flow is a light-curing, flowable, - Schütz Dental GmbH

Duns Number:315830349

Device Description: NanoPaq Flow is a light-curing, flowable, radiopaque, low viscosity composite.

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More Product Details

Catalog Number

-

Brand Name

NanoPaq Flow C 3, 2 g

Version/Model Number

234721

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Product Code Details

Product Code

EBC

Product Code Name

Sealant, Pit And Fissure, And Conditioner

Device Record Status

Public Device Record Key

a3c665cd-ffdf-4090-a147-f3c1651579ec

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 07, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SCHÜTZ DENTAL GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 390