BIODENTINE - Bioactive dentin substitute - SEPTODONT SAS SPECIALITES SEPTODONT

Duns Number:275273795

Device Description: Bioactive dentin substitute

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More Product Details

Catalog Number

01C0600

Brand Name

BIODENTINE

Version/Model Number

01C0600

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)

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

EJK

Product Code Name

Liner, Cavity, Calcium Hydroxide

Device Record Status

Public Device Record Key

b7f59722-cc6c-47ce-9fbf-852bc7320ed7

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 12, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SEPTODONT SAS SPECIALITES SEPTODONT" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5
2 A medical device with a moderate to high risk that requires special controls. 33
U Unclassified 1