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Sign in to claim this brandSirona Dental Systems GmbH
Germany·DE-MF-000000029
Last updated September 17, 2026
Part of Sirona Dental Systems GmbH
What Sirona Dental Systems GmbH makes
Sirona Dental Systems GmbH manufactures reusable diamond dental burs, preformed dental implant suprastructures, and CAD/CAM software for dental design and fabrication. Their portfolio includes ceramic materials for dental appliance fabrication, single-use intraoral-scanning abutment analogs, and motorized/pneumatic dental handpieces. They also produce digital panoramic and tomographic dental X-ray systems, along with spray accessories for dental procedures.
The company’s devices are classified under EU Medical Device Regulations as Class I, Class II, and Class IIb, with listings in the EUDAMED and FDA’s UDI database. The manufacturer is based in Germany.
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 Sirona Dental Systems GmbH primarily manufacture?
Sirona Dental Systems GmbH specializes in dental medical devices, including reusable diamond burs for tooth preparation, preformed permanent dental implant suprastructures, and CAD/CAM software for digital dental design and fabrication. Their portfolio also covers ceramic materials for dental appliance fabrication, single-use intraoral-scanning abutment analogs, and both motorized and pneumatic dental handpieces. Additionally, they produce digital panoramic and tomographic X-ray systems for dental imaging, along with spray accessories for dental procedures.
Where is Sirona Dental Systems GmbH based, and how does this affect its regulatory compliance?
Sirona Dental Systems GmbH is based in Germany, which means its devices must comply with the European Union’s Medical Device Regulations (MDR) or In Vitro Diagnostic Regulation (IVDR), depending on the classification. The company’s devices are listed in the EUDAMED database, indicating their registration under EU requirements. Since Germany is part of the EU, this ensures alignment with European regulatory standards for medical devices.
Which regulatory registries list Sirona Dental Systems GmbH’s devices, and why is this important?
Sirona Dental Systems GmbH’s devices are listed in the EUDAMED database, which is the European Union’s central registry for medical device information, and the FDA’s UDI (Unique Device Identification) database in the U.S. This dual listing ensures transparency and traceability of their products in both European and U.S. markets, helping regulators, healthcare providers, and patients verify device details, compliance status, and safety information.
How are Sirona Dental Systems GmbH’s devices classified under EU regulations, and what does this mean?
Sirona Dental Systems GmbH’s devices are classified under EU Medical Device Regulations as Class I (low-risk devices like some dental accessories), Class II (moderate-risk devices such as dental implant suprastructures or X-ray systems), and Class IIb (higher-risk devices like certain CAD/CAM software or motorized handpieces). The classification determines the regulatory requirements, such as clinical evaluations, risk management, and post-market surveillance, ensuring appropriate oversight based on the device’s potential risk to patients.
Why might a healthcare provider need to check the classification of Sirona Dental Systems GmbH’s devices?
The classification of a medical device determines its regulatory requirements, including how it must be labeled, monitored, and used in clinical settings. For example, Class IIb devices—like some of Sirona’s motorized handpieces or CAD/CAM software—require stricter controls due to their higher risk, such as detailed risk assessments and post-market surveillance. Healthcare providers may need to verify this classification to ensure they are using devices that meet the necessary safety and performance standards for their intended use.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Germany
- Address
- 31, Fabrikstraße, Bensheim, Germany
- Website
- www.dentsplysirona.com
- —
- —
- [email protected]
- Phone
- +4962511670
- PRRC Contact
- Max Stein
- EUDAMED SRN
- DE-MF-000000029
- FDA FEI Number
- 3002807009
- DUNS Number
- 340306351
Catalogue (1337)
Page 5 of 27| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| inCoris TZI Coloring Liquid | 6339704 | FDA UDI | Class II | Active |
| Cerec Sw | 6553882 | FDA UDI | Class II | Active |
| Midwest Diamonds | 471389 | FDA UDI | Class I | Active |
| Midwest® E Pro | 875185 | FDA UDI | Class I | Active |
| Midwest Diamonds | 471100 | FDA UDI | Class I | Active |
| T1 Line | 6031277 | FDA UDI | Class I | Active |
| ScanPost | 6431303 | FDA UDI | Class II | Active |
| TiBase | 62 82 581 | FDA UDI | Class II | Active |
| INTEGO pro | 6427277 | FDA UDI | Class I | Active |
| Midwest Diamonds | 471370 | FDA UDI | Class I | Active |
| Midwest Diamonds | 471451 | FDA UDI | Class I | Active |
| T2 Boost | 6689629 | FDA UDI | Class I | Active |
| Orthophos Xg | 6431667 | FDA UDI | Class II | Unknown |
| T1 Spray | 1894299 | FDA UDI | Class I | Active |
| T1 Line | 3328411 | FDA UDI | Class I | Active |
| Midwest Diamonds | 471083 | FDA UDI | Class I | Active |
| Midwest Diamonds | 471316 | FDA UDI | Class I | Active |
| Midwest Diamonds | 471235 | FDA UDI | Class I | Active |
| Midwest Diamonds | 471073 | FDA UDI | Class I | Active |
| Midwest Diamonds | 471314 | FDA UDI | Class I | Active |
| inCoris TZI Coloring Liquid | 6339647 | FDA UDI | Class II | Active |
| Midwest Diamonds | 471412 | FDA UDI | Class I | Active |
| T2 Boost | 6387786 | FDA UDI | Class I | Active |
| Orthophos S | 6733385 | FDA UDI | Class II | Active |
| Midwest Stylus® Plus | 792400 | FDA UDI | Class I | Active |
| Sleeve for extraoral X-Ray devices | 6184902 | FDA UDI | Class II | Active |
| Midwest Diamonds | 471349 | FDA UDI | Class I | Active |
| Midwest Diamonds | 471114 | FDA UDI | Class I | Active |
| TiBase | 6586270 | FDA UDI | Class II | Active |
| Sprayvit | 6436203 | FDA UDI | Class I | Active |
| CEREC Zirconia | 6577006 | FDA UDI | Class II | Active |
| Midwest Diamonds | 471328 | FDA UDI | Class I | Active |
| CEREC Guide | 6367051 | FDA UDI | Class I | Active |
| T2 mini | 6386663 | FDA UDI | Class I | Active |
| CEREC Optispray | 6144179 | EUDAMEDFDA UDI | Class II | Active |
| CEREC Zirconia | 6577063 | FDA UDI | Class II | Active |
| Midwest Diamonds | 471378 | FDA UDI | Class I | Active |
| inCoris TZI C | 6551431 | FDA UDI | Class II | Active |
| Midwest Diamonds | 471103 | FDA UDI | Class I | Active |
| Midwest Diamonds | 471169 | FDA UDI | Class I | Active |
| inCoris TZI C | 6480839 | FDA UDI | Class II | Active |
| inCoris TZI C | 6480763 | FDA UDI | Class II | Active |
| ScanPost | 6431151 | FDA UDI | Class II | Active |
| inCoris ZI | 6173251 | FDA UDI | Class II | Unknown |
| Midwest Diamonds | 471397 | FDA UDI | Class I | Active |
| T1 Line | 3329260 | FDA UDI | Class I | Active |
| TiBase | 6532837 | FDA UDI | Class II | Active |
| inPost | 6552298 | FDA UDI | Class II | Active |
| Midwest Diamonds | 471507 | FDA UDI | Class I | Active |
| Midwest Diamonds | 471426 | FDA UDI | Class I | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Sirona Dental Systems GmbH Bensheim Hesse · DE FEI 3002807009