LuxaBond - Total Etch - Total Etch dual cure adhesive system. The perfect - DMG Chemisch-Pharmazeutische Fabrik GmbH

Duns Number:320744915

Device Description: Total Etch dual cure adhesive system. The perfect partner for all direct and indirect tech Total Etch dual cure adhesive system. The perfect partner for all direct and indirect techniques. Content: 1 bottle @ 5 ml Pre-Bond, 1 bottle @ 5 ml Bond A, 1 bottle @ 5 ml Bond B, 1 syringe @ 2 ml DMG Etching Gel Medium Viscosity, Accessories.

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More Product Details

Catalog Number

212384

Brand Name

LuxaBond - Total Etch

Version/Model Number

212384

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

K063444,K131248

Product Code Details

Product Code

KLE

Product Code Name

Agent, Tooth Bonding, Resin

Device Record Status

Public Device Record Key

6a1c1075-56dc-497c-904a-20bb8f0c1ae5

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

-

"DMG CHEMISCH-PHARMAZEUTISCHE FABRIK GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 24
2 A medical device with a moderate to high risk that requires special controls. 143