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Sign in to claim this brandR-Dental Dentalerzeugnisse GmbH
US
Last updated May 30, 2026
What R-Dental Dentalerzeugnisse GmbH makes
R-Dental Dentalerzeugnisse GmbH manufactures silicone-based dental impression materials designed for capturing precise oral scans and impressions. Their portfolio includes products like the R-SI-LINE series, which includes variants such as METAL-BITE Blue, MONO S SCAN, and GOLD, as well as the KwikkModel SCAN and KWIKKMODEL for digital and traditional impression workflows.
These devices are classified as Class II under FDA regulations and are listed via 510(k) premarket notifications and the FDA’s Unique Device Identifier (UDI) system. The manufacturer operates within 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 R-Dental Dentalerzeugnisse GmbH manufacture?
R-Dental Dentalerzeugnisse GmbH specializes in silicone dental impression materials. These products are designed specifically for capturing detailed oral impressions, which are essential for creating dental prosthetics, orthodontic appliances, or digital scans. The company’s portfolio includes materials like the R-SI-LINE series (e.g., METAL-BITE variants) and KwikkModel products, which cater to both traditional and digital workflows in dentistry.
Where is R-Dental Dentalerzeugnisse GmbH based?
The company is based in the United States. This geographic location influences its regulatory compliance, particularly with U.S. authorities like the FDA, which governs the classification and listing of its devices.
Which regulatory registries or databases list R-Dental’s devices?
R-Dental’s devices are listed in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identifier (UDI) system. These registries ensure traceability and compliance with U.S. medical device regulations, particularly for Class II devices like their silicone impression materials.
How are R-Dental’s dental impression materials classified under FDA regulations?
R-Dental’s silicone dental impression materials fall under Class II classification by the FDA. This classification is typically assigned to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. The company’s products are subject to these regulatory requirements, including premarket submissions like 510(k)s and UDI compliance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- r-dental.com
- —
- —
- [email protected]
- Phone
- +4940307070730
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 313956880
Catalogue (7)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| R-SI-LINE ® METAL-BITE ® Blue | MBK0475 | FDA UDI | Class II | Active |
| R-Si-Line ® Mono S Scan | MOK0475 | FDA UDI | Class II | Active |
| R-Si-Line ® Metal-Bite ® | MBK1074 | FDA UDI | Class II | Active |
| KwikkModel ® SCAN | KMK1088 | FDA UDI | Class II | Active |
| R-Si-Line ® Metal-Bite ® Gold | MBK0750 | FDA UDI | Class II | Active |
| R-Si-Line Metal-Bite | K010926 | FDA 510(k) | Class II | Active |
| Kwikkmodel | K001414 | FDA 510(k) | Class II | Active |
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