Flowable Microfill Basic Kit - Flowable Microfill Basic Kit includes 11 (3 g) - COSMEDENT, INC.

Duns Number:113911689

Device Description: Flowable Microfill Basic Kit includes 11 (3 g) syringes of Flowable Microfill, and 50 tips Flowable Microfill Basic Kit includes 11 (3 g) syringes of Flowable Microfill, and 50 tips (25 - 18 gauge, 25 - 19 gauge) in the Tray.

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More Product Details

Catalog Number

301005

Brand Name

Flowable Microfill Basic Kit

Version/Model Number

301005

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

-

Product Code Name

-

Device Record Status

Public Device Record Key

0df598de-c788-4762-a281-594838d0ac37

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"COSMEDENT, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 161
2 A medical device with a moderate to high risk that requires special controls. 311