Device
Light-curing resinf based on (meth)acrylate for the production of dental devices. For DLP/ SLA printers that work at wavelengths of 385 nm and 405 nm. Content: 1 Canister @ 5 kg
Manufacturer
DMG Digital Enterprises SE
DMG Digital Enterprises SE
Model: 171619
Catalog: 171619
DI: D9821716190
Status: Update
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-06
Current Version: 2026-05-27
Description
Light-curing resinf based on (meth)acrylate for the production of dental devices. For DLP/ SLA printers that work at wavelengths of 385 nm and 405 nm. Content: 1 Canister @ 5 kg
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
2
Record Key:
be138704-0a67-44f8-b76f-36f83cca18f4
Distribution Status:
In Commercial Distribution
DUNS Number:
342962296
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
D9821716190
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 16730
Name: Dental appliance fabrication material, resin
Definition:
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.
FDA Product Codes
QJJ
Indirect Bonding Tray
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value:
15
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value:
25
Storage Handling - Storage Handling Type:
Storage Environment Temperature