LuxaPrint Ortho Plus 385 - (Meth) acrylate-based light-curing resin - DMG Chemisch-Pharmazeutische Fabrik GmbH

Duns Number:320744915

Device Description: (Meth) acrylate-based light-curing resin exclusively for use in the dental laboratory. For (Meth) acrylate-based light-curing resin exclusively for use in the dental laboratory. For DLP/ STL printers at a wavelength of 405 nm or 385 nm. High spirits in 3D. Content: 1 Bottle @ 500 g

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More Product Details

Catalog Number

171210

Brand Name

LuxaPrint Ortho Plus 385

Version/Model Number

171210

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 24, 2019

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

-

Product Code Details

Product Code

DYT

Product Code Name

Maintainer, Space Preformed, Orthodontic

Device Record Status

Public Device Record Key

75926cf7-36bf-475b-b9b9-b8959b4b6cc6

Public Version Date

November 10, 2021

Public Version Number

3

DI Record Publish Date

June 24, 2019

Additional Identifiers

Package DI Number

EDMG1712101

Quantity per Package

1

Contains DI Package

EDMG1712100

Package Discontinue Date

June 24, 2019

Package Status

Not in Commercial Distribution

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