FLEXITIME EASY PUTTY 1 X 600 ML - Dental Composite resin - Heraeus Kulzer GmbH

Duns Number:315666321

Device Description: Dental Composite resin

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More Product Details

Catalog Number

66002103

Brand Name

FLEXITIME EASY PUTTY 1 X 600 ML

Version/Model Number

66002103

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

Yes

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

K000629

Product Code Details

Product Code

ELW

Product Code Name

MATERIAL, IMPRESSION

Device Record Status

Public Device Record Key

4317373c-b4fa-41d8-aecb-bcbd0228d0dc

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HERAEUS KULZER GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7
2 A medical device with a moderate to high risk that requires special controls. 5609