Select Orange Vanilla Medium Prophy Paste (200) - BURKHART DENTAL SUPPLY CO., THE

Duns Number:027532357

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


More Product Details

Catalog Number

-

Brand Name

Select Orange Vanilla Medium Prophy Paste (200)

Version/Model Number

72721451

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"

Yes

For Single-Use

Yes

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

EJR

Product Code Name

Agent, Polishing, Abrasive, Oral Cavity

Device Record Status

Public Device Record Key

ed8a866f-c82a-4517-a461-30b9b47d9b8b

Public Version Date

April 26, 2019

Public Version Number

1

DI Record Publish Date

April 18, 2019

Additional Identifiers

Package DI Number

00815878021893

Quantity per Package

200

Contains DI Package

00815878021886

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"BURKHART DENTAL SUPPLY CO., THE" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 214
2 A medical device with a moderate to high risk that requires special controls. 43