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Sign in to claim this brandDMG Chemisch-Pharmazeutische Fabrik GmbH
US
Last updated May 24, 2026
What DMG Chemisch-Pharmazeutische Fabrik GmbH makes
DMG manufactures dental materials including composite resins for fillings, silicone-based impression materials for molds, and temporary crowns and bridges for restorative procedures. Their portfolio also includes single-use injection cannulas for dental applications, bonding agents for tooth preparation, glass ionomer cements for restorations, and unfilled resin coatings and sealants for protecting tooth surfaces.
The company’s devices are regulated under FDA classifications, with most falling into Class I and Class II categories, and are listed via 510(k) premarket notifications and the FDA’s Unique Device Identifier (UDI) system. The manufacturer operates 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 dental devices does DMG Chemisch-Pharmazeutische Fabrik GmbH manufacture?
DMG specializes in dental materials used for restorative and protective procedures. Their portfolio includes dental composite resins for fillings, silicone-based impression materials for creating molds of teeth, temporary crowns and bridges for interim restorations, and single-use injection cannulas for precise material application. They also produce bonding agents for tooth preparation, glass ionomer cements for durable restorations, and unfilled resin sealants or coatings to protect tooth surfaces from decay.
Where is DMG Chemisch-Pharmazeutische Fabrik GmbH based, and what regulatory framework applies to its devices?
DMG is based in the United States. Its devices are regulated under the FDA’s classification system, with most falling into Class I (generally low-risk devices) or Class II (devices requiring special controls to ensure safety and effectiveness). The company submits its devices through 510(k) premarket notifications and ensures compliance with the FDA’s Unique Device Identifier (UDI) system, which helps track and monitor devices throughout their lifecycle.
Which regulatory registries or databases list DMG’s dental devices?
DMG’s devices are listed in the FDA’s 510(k) premarket notification database, where manufacturers demonstrate that their products are substantially equivalent to legally marketed predicates. Additionally, their devices are included in the FDA’s Unique Device Identifier (UDI) system, which standardizes identification for better tracking, safety monitoring, and regulatory compliance. These registries help ensure transparency and traceability of dental materials in the U.S. market.
How are DMG’s dental devices classified under FDA regulations?
DMG’s devices are classified under the FDA’s risk-based system, with the majority falling into Class I (low-risk, general controls sufficient) or Class II (moderate-risk, requiring additional performance standards or post-market surveillance). For example, single-use cannulas or unfilled resin sealants may qualify as Class I, while composite resins or bonding agents—due to their direct contact with teeth and potential long-term effects—often fall under Class II. The classification determines the regulatory pathway, such as 510(k) submissions or other compliance requirements.
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
- 320744915
Catalogue (221)
Page 3 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| LuxaFlow® | 211751 | FDA UDI | Class II | Active |
| Tray Adhesive for A-Silicones | 999394 | FDA UDI | Class I | Active |
| Constic A3 | 220702 | FDA UDI | Class II | Active |
| LuxaCore® Z Dual | 213331 | FDA UDI | Class II | Active |
| Honigum Pro Trail Kit | 989501 | FDA UDI | Class II | Active |
| LuxaCrown | 120973 | FDA UDI | Class II | Active |
| Vitique | 213043 | FDA UDI | Class II | Active |
| Luxatemp® Fluorescence | 110722 | FDA UDI | Class II | Active |
| LuxaBite | 110560 | FDA UDI | Class II | Active |
| Ionosit Baseliner | 223002 | FDA UDI | Class II | Active |
| Luxatemp® Automix Plus | 110406 | FDA UDI | Class II | Active |
| DeltaFil | 540001 | FDA UDI | Class II | Active |
| LuxaPost | 110734 | FDA UDI | Class I | Active |
| Smartmix-Tips Combi | 212042 | FDA UDI | Class I | Active |
| LuxaPost | 110783 | FDA UDI | Class I | Active |
| PermaCem Smartmix Dual | 212035 | FDA UDI | Class II | Active |
| Honigum Light | 999539 | FDA UDI | Class II | Active |
| Luxatemp® Ultra | 110911 | FDA UDI | Class II | Active |
| Honigum Pro Heavy | 989766 | FDA UDI | Class II | Active |
| Vitique | 213051 | FDA UDI | Class II | Active |
| DeltaFil | 540000 | FDA UDI | Class II | Active |
| DeltaFil | 540010 | FDA UDI | Class II | Active |
| Endobrushes | 212386 | FDA UDI | Class I | Active |
| LuxaPrint Ortho 405 | 171257 | FDA UDI | Class I | Unknown |
| StatusBlue MixStar | 999693 | FDA UDI | Class II | Active |
| Ecosite Bulk Fill | 220753 | FDA UDI | Class II | Active |
| LuxaPost | 110780 | FDA UDI | Class I | Active |
| LuxaCore® Z Dual | 213335 | FDA UDI | Class II | Active |
| Ecosite Elements | 220801 | FDA UDI | Class II | Active |
| Luxatemp® Automix Plus | 110402 | FDA UDI | Class II | Active |
| Smartmix Tips Blue-Green | 110991 | FDA UDI | Class I | Active |
| Vitique | 213052 | FDA UDI | Class II | Active |
| LuxaCrown | 120971 | FDA UDI | Class II | Active |
| LuxaPrint Ortho 385 | 171206 | FDA UDI | Class I | Unknown |
| Honigum Pro Heavy Quad Fast | 989638 | FDA UDI | Class II | Active |
| Luxatemp® Automix Plus | 110401 | FDA UDI | Class II | Active |
| Luxatemp® Ultra | 110908 | FDA UDI | Class II | Active |
| O-Bite | 999765 | FDA UDI | Class II | Active |
| LuxaFlow® Ultra BL | 224008 | FDA UDI | Class II | Active |
| Vitique | 213054 | FDA UDI | Class II | Active |
| Icon® | 220400 | FDA UDI | Class II | Active |
| LuxaCrown | 120975 | FDA UDI | Class II | Active |
| Honigum Heavy | 999766 | FDA UDI | Class II | Active |
| TempoCem®NE Automix | 110302 | FDA UDI | Class II | Active |
| LuxaPrint Ortho Plus 385 | 171259 | FDA UDI | Class I | Unknown |
| Luxatemp® Automix Plus | 110404 | FDA UDI | Class II | Active |
| Honigum Heavy Quad Fast | 999838 | FDA UDI | Class II | Active |
| TempoCem® Automix | 212129 | FDA UDI | Class I | Active |
| Vitique | 213042 | FDA UDI | Class II | Active |
| LuxaPrint Ortho Plus 405 | 171213 | FDA UDI | Class I | Unknown |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Dmg Chemisch Pharmazeutische Fabrik Gmbh HAMBURG · DE FEI 3004150030