AccessGUDID - DEVICE: LuxaPrint Ortho Plus 385 (EDMG1712110)

GUDID

Device Identifier (DI) Information

Brand Name: LuxaPrint Ortho Plus 385
Version or Model: 171211
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 171211
Company Name: DMG Chemisch-Pharmazeutische Fabrik GmbH

Primary DI Number: EDMG1712110
Issuing Agency: HIBCC
Commercial Distribution End Date: June 24, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 320744915 *Terms of Use

Device Description: (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 @ 1000 g

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
16730	Dental appliance fabrication material, resin	A resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DYT	Maintainer, Space Preformed, Orthodontic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store in a location that is protected against light. Always keep the container tightly sealed.
Handling Environment Temperature: between 15 and 25 Degrees Celsius
Handling Environment Temperature: between 59 and 77 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d0c660aa-7e69-46f0-8826-c47f43c5d2f9
Public Version Date: November 10, 2021
Public Version Number: 3
DI Record Publish Date: June 24, 2019