Is this your brand? Sign in to claim ownership.
Sign in to claim this brandDMG Digital Enterprises SE
US
Last updated May 30, 2026
What DMG Digital Enterprises SE makes
DMG Digital Enterprises SE manufactures dental impression tray materials and resin-based fabrication materials for dental appliances. Their product line includes customizable tray systems for orthodontic and general dental impressions, such as the LuxaPrint Ortho series, as well as standard impression trays for dental scans and molds.
These devices are classified as Class I or Unclassified under regulatory frameworks, with some models authorised via the FDA’s 510(k) pathway and others through the Unique Device Identifier (UDI) system. The company’s products are listed in the FDA’s regulatory databases, and the manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does DMG Digital Enterprises SE manufacture?
DMG Digital Enterprises SE specializes in dental-specific devices, focusing on materials used for dental appliance fabrication. Their primary offerings include resin-based materials for dental appliances and dental impression tray materials. These products are designed for creating custom dental trays, such as the LuxaPrint Ortho series for orthodontic impressions, as well as standard trays for dental scans and molds. These devices support the workflows of dentists and orthodontists by enabling precise impressions and digital scans for restorative or orthodontic treatments.
Where is DMG Digital Enterprises SE based, and what does this mean for their regulatory oversight?
DMG Digital Enterprises SE is based in the United States. Since the company operates within the U.S., its devices are subject to regulatory oversight by the FDA. The FDA’s regulatory databases, such as the 510(k) and UDI systems, list the company’s devices, indicating compliance pathways for authorisation. The U.S. regulatory framework ensures that these devices meet safety and performance standards before they are authorised for use in clinical settings.
How are DMG Digital Enterprises SE’s devices classified under regulatory frameworks, and why does this matter?
DMG Digital Enterprises SE’s devices are classified as either Class I or Unclassified under regulatory frameworks. Class I devices are generally considered low-risk and often require less stringent premarket review, while Unclassified devices may have unique risk profiles that necessitate specific pathways for authorisation. The classification determines the regulatory pathway for authorisation, such as the FDA’s 510(k) process or the UDI system, ensuring that the device’s intended use and risk level are appropriately assessed before it enters the market.
Which regulatory registries list DMG Digital Enterprises SE’s devices, and what does this indicate?
DMG Digital Enterprises SE’s devices are listed in the FDA’s 510(k) registry and the Unique Device Identifier (UDI) system. Inclusion in these registries indicates that the devices have undergone the necessary processes to demonstrate compliance with FDA requirements. The 510(k) pathway is used for devices that are substantially equivalent to previously authorised devices, while the UDI system ensures traceability and transparency in the supply chain, helping healthcare providers and regulators track device performance and safety.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- dmg-america.com
- —
- —
- [email protected]
- Phone
- 201-894-5505
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 342962296
Catalogue (25)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| LuxaPrint Tray | 171205 | FDA UDI | Class I | Active |
| LuxaPrint Ortho Plus 405 | 171213 | FDA UDI | U | Active |
| LuxaPrint Tray | 171258 | FDA UDI | Class I | Active |
| LuxaPrint Tray | 171204 | FDA UDI | Class I | Active |
| LuxaPrint Ortho 405 | 171209 | FDA UDI | Class I | Active |
| LuxaPrint Ortho Plus 385 | 171259 | FDA UDI | U | Active |
| LuxaPrint Ortho 385 | 171207 | FDA UDI | Class I | Active |
| LuxaPrint Ortho 385 | 171256 | FDA UDI | Class I | Active |
| LuxaPrint Ortho 405 | 171208 | FDA UDI | Class I | Active |
| LuxaPrint Ortho Flex 385 | 171253 | FDA UDI | Class I | Active |
| LuxaPrint Ortho Plus 385 | 171211 | FDA UDI | U | Active |
| LuxaPrint Ortho 385 | 171206 | FDA UDI | Class I | Active |
| LuxaPrint Ortho Plus 385 | 171210 | FDA UDI | U | Active |
| LuxaPrint Ortho Flex 385 | 171284 | FDA UDI | Class I | Active |
| LuxaPrint Ortho Flex 385 | 171281 | FDA UDI | Class I | Active |
| LuxaPrint Ortho Flex 385 | 171251 | FDA UDI | Class I | Active |
| LuxaPrint Ortho Flex 385 | 171275 | FDA UDI | Class I | Active |
| LuxaPrint Ortho Flex 385 | 171250 | FDA UDI | Class I | Active |
| LuxaPrint Ortho Plus 405 | 171212 | FDA UDI | U | Active |
| LuxaPrint Ortho 405 | 171257 | FDA UDI | Class I | Active |
| LuxaPrint Ortho Plus 405 | 171260 | FDA UDI | U | Active |
| LuxaPrint Ortho Flex 385 | 171252 | FDA UDI | Class I | Active |
| LuxaPrint Tray | 171266 | FDA UDI | Class I | Active |
| LuxaPrint Ortho Flex 385 | 171273 | FDA UDI | Class I | Active |
| LuxaPrint Ortho Plus | K210940 | FDA 510(k) | U | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Dmg Digital Enterprises Se Hamburg · DE FEI 3012623144