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Sign in to claim this brandDentsply Professional
US
Last updated May 24, 2026
What Dentsply Professional makes
Dentsply Professional manufactures ceramic materials for dental appliance fabrication, including high-strength dental ceramics like Ceramco 3, used in crowns, bridges, and other restorative applications. Their portfolio also includes ultrasonic dental scaling systems, such as the Cavitron®, along with specialized handpiece tips for periodontal debridement and single-use polishing cups for dental procedures. Additional products include dental cavity varnishes, irrigation handpieces for delivery systems, and resin-based artificial teeth like Lucitone Digital IPN 3D Premium Tooth.
The company’s devices are regulated under the FDA’s classification system, with products falling into Class I and Class II categories. These devices are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. medical device regulations. The manufacturer operates from 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 Dentsply Professional manufacture?
Dentsply Professional specializes in dental devices, primarily focusing on materials and systems for restorative and cleaning procedures. Their portfolio includes high-strength ceramic materials like Ceramco 3 for dental appliance fabrication (such as crowns and bridges), ultrasonic dental scaling systems like Cavitron® for plaque removal, periodontal handpiece tips, single-use polishing cups, dental cavity varnishes, irrigation handpieces, and resin-based artificial teeth like Lucitone Digital IPN 3D Premium Tooth. These products cater to both restorative and hygiene needs in dentistry.
Where is Dentsply Professional based, and how does that affect its devices?
Dentsply Professional is headquartered in the United States, which means its devices are subject to U.S. regulatory requirements, including FDA oversight. Since the company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, they comply with U.S. traceability and compliance standards for medical devices. This ensures their devices meet the necessary regulatory criteria for distribution and use in the American market.
Which regulatory registries list Dentsply Professional’s devices?
Dentsply Professional’s devices are included in the FDA’s Unique Device Identifier (UDI) database. The UDI system assigns a unique product code to each device, enabling better tracking, transparency, and compliance with U.S. medical device regulations. This registry helps healthcare providers and regulators verify device details, such as manufacturer information and classification.
How are Dentsply Professional’s devices classified under U.S. regulations?
Dentsply Professional’s devices fall into two main FDA classification categories: Class I and 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 require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and regulatory history, ensuring appropriate oversight for each product.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- dentsplysirona.com
- —
- —
- [email protected]
- Phone
- +1(800)243-1942
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 144140845
Catalogue (526)
Page 4 of 11| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Sani-Tip® | 122220N | FDA UDI | Class I | Active |
| Ceramco 3 | 305212 | FDA UDI | Class II | Active |
| Lucitone Digital IPN 3D Premium Tooth | 906396 | FDA UDI | Class II | Active |
| Ceramco 3 | 303280 | FDA UDI | Class II | Active |
| Ceramco 3 | 305143 | FDA UDI | Class II | Active |
| Nupro® | 130325 | FDA UDI | Class II | Active |
| Ceramco 3 | 305205 | FDA UDI | Class II | Active |
| Cavitron® | 8129501 | FDA UDI | Class II | Active |
| Cavitron® | 82004 | FDA UDI | Class II | Active |
| Ceramco 3 | 305148 | FDA UDI | Class II | Active |
| SofScale™ | A900300 | FDA UDI | Class II | Active |
| Ceramco 3 | 303480 | FDA UDI | Class II | Active |
| Cavitron® | 6121702 | FDA UDI | Class II | Active |
| Ceramco 3 | 303560 | FDA UDI | Class II | Active |
| Ceramco 3 | 305008 | FDA UDI | Class II | Active |
| Ceramco 3 | 305109 | FDA UDI | Class II | Active |
| Cavitron® | 8800008 | FDA UDI | Class II | Active |
| Nupro® | 130218 | FDA UDI | Class II | Active |
| Cavitron® | 80796 | FDA UDI | Class II | Active |
| Cavitron® | 80798 | FDA UDI | Class II | Active |
| Ceramco 3 | 305208 | FDA UDI | Class II | Active |
| Ceramco 3 | 303100 | FDA UDI | Class II | Active |
| Cavitron® | 8161426 | FDA UDI | Class II | Unknown |
| Cavitron® | 80401 | FDA UDI | Class II | Active |
| Ceramco 3 | 305909 | FDA UDI | Class II | Active |
| Nupro® | 965066 | FDA UDI | Class I | Active |
| Cavitron® | 90147 | FDA UDI | Class I | Active |
| Disposa-Shield® | A88008 | FDA UDI | Class II | Active |
| Nupro® | 130083 | FDA UDI | Class I | Active |
| Ceramco 3 | 303110 | FDA UDI | Class II | Active |
| Ceramco 3 | 305402 | FDA UDI | Class II | Active |
| Ceramco 3 | 305902 | FDA UDI | Class II | Active |
| Cavitron® DualSelect™ | 80528 | FDA UDI | Class I | Active |
| Ceramco 3 | 303900 | FDA UDI | Class II | Active |
| Ceramco 3 | 305207 | FDA UDI | Class II | Active |
| Ceramco 3 | 303250 | FDA UDI | Class II | Active |
| Ceramco 3 | 305013 | FDA UDI | Class II | Active |
| Midwest® Rdh® | 740020 | FDA UDI | Class I | Active |
| Ceramco 3 | 305003 | FDA UDI | Class II | Active |
| Cavitron® | 81340 | FDA UDI | Class II | Unknown |
| Cavitron® | 8161424 | FDA UDI | Class II | Active |
| Cavitron® | 6120102 | FDA UDI | Class II | Active |
| Cavitron® | 90411 | FDA UDI | Class II | Active |
| Nupro® | 965064 | FDA UDI | Class I | Active |
| Nupro® | 130214 | FDA UDI | Class II | Active |
| Lucitone Digital IPN 3D Premium Tooth | 906382 | FDA UDI | Class II | Active |
| Cavitron® | 79612 | FDA UDI | Class II | Active |
| Sani-Tip® | 122383N | FDA UDI | Class I | Active |
| Cavitron® | 8170203 | FDA UDI | Class II | Active |
| Ceramco 3 | 305132 | FDA UDI | Class II | Active |
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