Ena HRI ® - Ena HRi Bio Dentine BD3 2.5g Light Curing - MICERIUM SPA

Duns Number:436661136

Device Description: Ena HRi Bio Dentine BD3 2.5g Light Curing Composite

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More Product Details

Catalog Number

ERBD3

Brand Name

Ena HRI ®

Version/Model Number

ERBD3

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K062906

Product Code Details

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Device Record Status

Public Device Record Key

39f25238-b2e8-426e-b968-254923481c05

Public Version Date

July 23, 2018

Public Version Number

1

DI Record Publish Date

June 20, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MICERIUM SPA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 32
2 A medical device with a moderate to high risk that requires special controls. 231