Prime Dent Flowable Composite Shade A2 - Prime Dent Flowable Composite Shade A2- 4.5g - PRIME DENTAL

Duns Number:027480775

Device Description: Prime Dent Flowable Composite Shade A2- 4.5g Syringe

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More Product Details

Catalog Number

-

Brand Name

Prime Dent Flowable Composite Shade A2

Version/Model Number

004-101A2

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)

-

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

f1727a28-32a7-41f3-8fdb-00da1a6c2d9a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 04, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PRIME DENTAL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 11