Quala - Quala Core Buildup Dual Cure 2x9G 20 Mix Tip - NATIONAL DISTRIBUTION & CONTRACTING, INC.

Duns Number:009831413

Device Description: Quala Core Buildup Dual Cure 2x9G 20 Mix Tip

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More Product Details

Catalog Number

Q40201

Brand Name

Quala

Version/Model Number

Q40201

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

EBF

Product Code Name

Material, Tooth Shade, Resin

Device Record Status

Public Device Record Key

c35f5f18-b551-47a1-8c73-ab2b627e1dcb

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 13, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NATIONAL DISTRIBUTION & CONTRACTING, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 224
2 A medical device with a moderate to high risk that requires special controls. 192