AccessGUDID - DEVICE: LuxaPrint Ortho 405 (D9821712090)

GUDID

Device Identifier (DI) Information

Brand Name: LuxaPrint Ortho 405
Version or Model: 171209
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 171209
Company Name: DMG Digital Enterprises SE

Primary DI Number: D9821712090
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 342962296 *Terms of Use

Device Description: (Meth) acrylate-based light-curing resin for the fabrication of surgical guides and splints. For DLP/ STL printers at a wavelength of 405 nm or 385 nm. High spirits in 3D. Content: 1 Bottle @ 1 kg

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
NDP	Accessories, Implant, Dental, Endosseous
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 dry place and protected from light! Always keep the container tightly sealed. Carefully seal immediately after every use.
Storage Environment Temperature: between 15 and 25 Degrees Celsius
Storage Environment Temperature: between 59 and 77 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d419187e-2a76-4efe-92dd-3ef6a8c03149
Public Version Date: September 09, 2022
Public Version Number: 1
DI Record Publish Date: September 01, 2022