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Sign in to claim this brandEisenbacher Dentalwaren ED GmbH
US
Last updated May 24, 2026
What Eisenbacher Dentalwaren ED GmbH makes
The company produces dental casting alloys, including non-noble alloys for dental applications, as well as custom-made polymer dental crowns. Their product line includes pre-sized discs for dental casting, such as Kera Ti5-Disc and Kera-Disc variants, and custom polymer crowns like Kera NH.
These devices are regulated under FDA classification as Class I and Class II, with listings maintained in the FDA’s Unique Device Identification (UDI) system. The company 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 Eisenbacher Dentalwaren ED GmbH manufacture?
Eisenbacher Dentalwaren ED GmbH specializes in dental devices, specifically dental casting non-noble alloys and custom-made dental crowns made from polymer materials. Their product line includes pre-sized discs for dental casting, such as the Kera Ti5-Disc and Kera-Disc series, which are used in dental laboratories for creating crowns, bridges, or other restorations. These materials are designed for precision casting and custom fabrication in dental applications.
Where is Eisenbacher Dentalwaren ED GmbH based?
The company is based in the United States. While the name suggests a German origin (common in dental materials), its operational headquarters and regulatory filings are associated with the US market.
Which regulatory registries list Eisenbacher Dentalwaren ED GmbH’s devices?
The company’s devices are listed in the FDA’s Unique Device Identification (UDI) system. This registry ensures traceability and transparency of dental devices under FDA oversight, allowing healthcare providers and regulators to identify and track specific products like the Kera Ti5-Disc or Kera-Disc variants.
How are Eisenbacher Dentalwaren ED GmbH’s devices classified under FDA regulations?
The company’s devices fall under FDA classification as either Class I or Class II. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the manufacturing process, as seen with their dental casting alloys and custom polymer crowns.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 344231006
Catalogue (93)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Kera-Disc 99, 5 x 15 mm | 10041115 | FDA UDI | Class II | Active |
| Dentium | 1004015 | FDA UDI | Class II | Active |
| Kera-Disc 98, 3 x 12 mm | 10041212 | FDA UDI | Class II | Active |
| Kera Ti5-Disc 98, 5 x 10 mm | T10045210 | FDA UDI | Class II | Active |
| Kera Ti5-Disc 98, 5 x 10 mm | 10045210 | FDA UDI | Class II | Active |
| Kera-Disc 98, 3 x 24, 5 mm | D10041224 | FDA UDI | Class II | Active |
| Kera-Disc 99, 5 x 8 mm | 10041108 | FDA UDI | Class II | Active |
| Kera Ti5-Disc 99, 5 x 15 mm | 10045115 | FDA UDI | Class II | Active |
| Kera-Disc 99, 5 x 8 mm | D10041108 | FDA UDI | Class II | Active |
| Kera-Disc 99, 5 x 24, 5 mm | D10041124 | FDA UDI | Class II | Active |
| Kera-Disc 98, 3 x 17, 5 mm | 10041217 | FDA UDI | Class II | Active |
| Kera-Disc 99, 5 x 16 mm | D10041116 | FDA UDI | Class II | Active |
| Kera Ti5-Disc 98, 5 x 8 mm | 10045208 | FDA UDI | Class II | Active |
| Kera®Soft-Disc 98, 0 x 16 mm | 13041216 | FDA UDI | Class II | Active |
| Robur 400 | 1004003 | FDA UDI | Class II | Active |
| Kera®Soft-Disc 98, 0 x 18 mm | 13041218 | FDA UDI | Class II | Active |
| Kera Ti5-Disc 99, 5 x 25 mm | T10045125 | FDA UDI | Class II | Active |
| Kera Ti5-Disc 99, 5 x 20 mm | 10045120 | FDA UDI | Class II | Active |
| Kera Ti5-Disc 98, 5 x 18 mm | T10045218 | FDA UDI | Class II | Active |
| Kera Ti5-Disc 98, 5 x 16 mm | 10045216 | FDA UDI | Class II | Active |
| Kera-Disc 98, 3 x 20 mm | D10041220 | FDA UDI | Class II | Active |
| Kera C | 1004004 | FDA UDI | Class II | Active |
| Kera®starSplint Bio | 11051216 | FDA UDI | Class I | Active |
| Kera-Disc 98, 3 x 12 mm | D10041212 | FDA UDI | Class II | Active |
| Kera-Disc 99, 5 x 15 mm | D10041115 | FDA UDI | Class II | Active |
| Kera Ti5-Disc 99, 5 x 16 mm | 10045116 | FDA UDI | Class II | Active |
| Kera-Disc 99, 5 x 20 mm | 10041120 | FDA UDI | Class II | Active |
| Kera Ti5-Disc 98, 5 x 14 mm | 10045214 | FDA UDI | Class II | Active |
| Kera Ti5-Disc 98, 5 x 27 mm | T10045227 | FDA UDI | Class II | Active |
| Vesco | 1004021 | FDA UDI | Class II | Active |
| Kera Ti5-Disc 99, 5 x 15 mm | T10045115 | FDA UDI | Class II | Active |
| Kera Ti5-Disc 98, 5 x 20 mm | T10045220 | FDA UDI | Class II | Active |
| Kera Ti5-Disc 99, 5 x 16 mm | T10045116 | FDA UDI | Class II | Active |
| Kera Ti5-Disc 98, 5 x 27 mm | 10045227 | FDA UDI | Class II | Active |
| Kera-Disc 99, 5 x 20 mm | D10041120 | FDA UDI | Class II | Active |
| Kera-Disc 98, 3 x 16 mm | D10041216 | FDA UDI | Class II | Active |
| Kera Ti5-Disc 98, 5 x 20 mm | 10045220 | FDA UDI | Class II | Active |
| Kera Ti5-Disc 98, 5 x 22 mm | T10045222 | FDA UDI | Class II | Active |
| Kera Ti5-Disc 98, 5 x 12 mm | T10045212 | FDA UDI | Class II | Active |
| Kera Ti5-Disc 98, 5 x 8 mm | T10045208 | FDA UDI | Class II | Active |
| Kera Ti5-Disc 98, 5 x 15 mm | 10045215 | FDA UDI | Class II | Active |
| Kera Ti5-Disc 98, 5 x 12 mm | 10045212 | FDA UDI | Class II | Active |
| Kera-Disc 98, 3 x 10 mm | 10041210 | FDA UDI | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Eisenbacher Dentalwaren Ed Gmbh WOERTH Bavaria · DE FEI 3004971271