KaVo PROPHYflex Perio Powder (4x Fl.) - KaVo Dental GmbH

Duns Number:333710619

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More Product Details

Catalog Number

Perio Powder 4 Fl

Brand Name

KaVo PROPHYflex Perio Powder (4x Fl.)

Version/Model Number

1.009.3732

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

EJR

Product Code Name

AGENT, POLISHING, ABRASIVE, ORAL CAVITY

Device Record Status

Public Device Record Key

b34c8b02-9931-45f9-86a2-4f6c4f9f7a17

Public Version Date

November 08, 2021

Public Version Number

4

DI Record Publish Date

September 26, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KAVO DENTAL GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 194
2 A medical device with a moderate to high risk that requires special controls. 153