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Sign in to claim this brandDreve Dentamid GmbH
US
Last updated May 24, 2026
What Dreve Dentamid GmbH makes
Dreve Dentamid GmbH manufactures dental materials used in appliance fabrication, impression-taking, and restorative procedures. Their portfolio includes thermoplastic and resin materials for dental appliances, silicone and tray materials for impressions, mixing nozzles for dental composites, bite registration waxes, and varnishes for dental restorations.
The company’s products are regulated under FDA Class I and Class II categories, with some devices listed via the 510(k) pathway and others under the UDI system. These materials are intended for use in dental laboratories and clinical settings 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 materials does Dreve Dentamid GmbH manufacture?
Dreve Dentamid GmbH specializes in dental materials primarily used for appliance fabrication, impression-taking, and restorative treatments. Their portfolio includes thermoplastic and resin materials for dental appliances, silicone and tray materials for dental impressions, mixing nozzles for dental composites, bite registration waxes, and varnishes for dental restorations. These materials are designed for both laboratory and clinical applications in dentistry.
Where is Dreve Dentamid GmbH based?
Dreve Dentamid GmbH is based in the United States, though it is important to note that the company itself is not a regulatory approval body—its products are individually evaluated for compliance with U.S. regulations.
Which regulatory registries or pathways list Dreve Dentamid GmbH’s devices?
Dreve Dentamid GmbH’s devices are listed under U.S. FDA pathways, specifically the 510(k) premarket notification process for some products and the UDI (Unique Device Identification) system for others. These pathways are used to demonstrate compliance with FDA requirements for dental materials, depending on their classification.
How are Dreve Dentamid GmbH’s dental materials classified under FDA regulations?
Dreve Dentamid GmbH’s devices fall under FDA Class I (generally low-risk materials like waxes or trays) and Class II (moderate-risk items such as impression materials or restorative varnishes). Classification determines the regulatory pathway—Class I devices often require less stringent review, while Class II may involve additional performance standards or 510(k) submissions to ensure safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- dreve.de
- —
- —
- [email protected]
- Phone
- +49230388070
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 388000846
Catalogue (310)
Page 1 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Folidur Align | 2110125100 | FDA UDI | Class I | Active |
| Drufosoft® | D4248X9 | FDA UDI | Class I | Active |
| Dynax® putty | D6101 | FDA UDI | Class II | Active |
| Drufosoft® | D42531 | FDA UDI | Class I | Active |
| Drufosoft® | D42511 | FDA UDI | Class I | Active |
| Fixtemp C&B | D603925 | FDA UDI | Class II | Unknown |
| Mixing tips | D4981 | FDA UDI | Class I | Active |
| Drufosoft® | D4248X8S | FDA UDI | Class I | Active |
| Drufosoft® | D4248X17 | FDA UDI | Class I | Active |
| Biolon | D420006SP | FDA UDI | Class I | Active |
| Dynax® heavy body | D6113 | FDA UDI | Class II | Active |
| Drufosoft® | D4248X3SQ | FDA UDI | Class I | Active |
| Biolon | D420006S | FDA UDI | Class I | Active |
| Folidur N | 2006SQ100 | FDA UDI | Class I | Active |
| Drufosoft® | D4248X6SQ | FDA UDI | Class I | Active |
| Drufosoft® | D4248X23 | FDA UDI | Class I | Active |
| Foliflex | 1010125100 | FDA UDI | Class I | Active |
| FotoDent® IBT 385 nm | D35120 | FDA UDI | Class I | Active |
| Regofix transparent | 1 | FDA UDI | Class II | Unknown |
| Biolon | D420008S | FDA UDI | Class I | Active |
| Plaquit | D38124 | FDA UDI | Class II | Unknown |
| FotoDent® guide | 1 | FDA UDI | Class I | Unknown |
| Folidur N | 2006125100 | FDA UDI | Class I | Active |
| Folidur N | 2015120050 | FDA UDI | Class I | Active |
| Folidur Align | 2108125100 | FDA UDI | Class I | Active |
| Mixing tips | D49701X1 | FDA UDI | Class I | Active |
| Combiloc Plus | 3040SQ050 | FDA UDI | Class I | Active |
| FotoDent® tray | D35300 | FDA UDI | Class I | Unknown |
| NanoVarnish | D38900 | FDA UDI | Class II | Unknown |
| StoneBite® | D504872 | FDA UDI | Class II | Active |
| Dynax® light | D6104 | FDA UDI | Class II | Active |
| Plaquit | D38123 | FDA UDI | Class II | Unknown |
| Drufosoft® | D4252 | FDA UDI | Class I | Active |
| Biolon | D420020S | FDA UDI | Class I | Active |
| Biolon | D420001 | FDA UDI | Class I | Active |
| FotoDent® tray2 | D353001 | FDA UDI | Class I | Active |
| Drufosoft® | D42483X25 | FDA UDI | Class I | Active |
| Biolon | D420010Q | FDA UDI | Class I | Active |
| Combiloc Plus | 3040120050 | FDA UDI | Class I | Active |
| Foliflex Pro | 1225120050 | FDA UDI | Class I | Active |
| Regofix opak | 1 | FDA UDI | Class II | Unknown |
| Zerosil soft | 1 | FDA UDI | Class II | Unknown |
| Odontosil 60 Shore | D5038160 | FDA UDI | Class I | Active |
| Drufosoft® | D42451SQ | FDA UDI | Class I | Active |
| Drufosoft® | D42483X9 | FDA UDI | Class I | Active |
| Biolon | D420022 | FDA UDI | Class I | Active |
| Biolon | D420006Q | FDA UDI | Class I | Active |
| Drufosoft® | D42483X26 | FDA UDI | Class I | Active |
| Drufosoft® | D4248X5SQ | FDA UDI | Class I | Active |
| FotoDent® tray2 | D353002 | FDA UDI | Class I | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Dreve Dentamid Gmbh UNNA North Rhine-Westphalia · DE FEI 1000486347