equilibrium® - 50 case assortment equilibrium® ti Brackets - DENTAURUM GmbH & Co.KG

Duns Number:315427286

Device Description: 50 case assortment equilibrium® ti Brackets McLaughlin 22

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More Product Details

Catalog Number

-

Brand Name

equilibrium®

Version/Model Number

891-358-00

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 27, 2018

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

-

Product Code Details

Product Code

EJF

Product Code Name

BRACKET, METAL, ORTHODONTIC

Device Record Status

Public Device Record Key

31f8676a-917f-4313-9246-fcf716ae032f

Public Version Date

April 27, 2018

Public Version Number

3

DI Record Publish Date

September 15, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DENTAURUM GMBH & CO.KG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2768
2 A medical device with a moderate to high risk that requires special controls. 1745