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Sign in to claim this brandDentsply De Trey GmbH
US
Last updated May 27, 2026
What Dentsply De Trey GmbH makes
Dentsply De Trey GmbH manufactures dental composite resins, including flowable and standard formulations like TPH Spectra ST, for restorative procedures. Their portfolio also includes endodontic materials such as AH Plus Jet and AH 26 for root canal sealing, along with dentine bonding agents like Prime&Bond active and dentine adhesives for tooth preparation. The company produces dental polymerization lamps, such as SmartLite Focus, for curing composite resins and epoxy-based materials, as well as single-component cartridge applicators for dispensing dental materials. Orthodontic pliers, including Automatrix Snippers+ Catch Tray, are also part of their product range for bracket placement and wire manipulation.
The company’s devices are classified under FDA’s Class I and Class II categories, with listings maintained in the FDA’s Unique Device Identifier (UDI) database. These products are intended for use in dental and endodontic procedures, adhering to regulatory requirements for medical devices in the United States. The manufacturer operates under U.S. jurisdiction, ensuring compliance with applicable FDA standards for dental materials and instruments.
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 De Trey GmbH manufacture?
Dentsply De Trey GmbH specializes in dental and endodontic devices. Their portfolio includes dental composite resins (like TPH Spectra ST) for tooth restoration, bonding agents (e.g., Prime&Bond active) for tooth preparation, endodontic filling/sealing materials (such as AH Plus Jet) for root canal treatment, polymerization lamps (e.g., SmartLite Focus) for curing dental materials, and single-component cartridge applicators for precise material dispensing. They also produce orthodontic pliers (like Automatrix Snippers+ Catch Tray) for bracket and wire adjustments.
Where is Dentsply De Trey GmbH based, and how does this affect its regulatory oversight?
Dentsply De Trey GmbH is based in the United States, which means its devices fall under FDA jurisdiction. Since the company manufactures dental and endodontic products, these devices are subject to FDA classification and regulatory requirements, including listing in the FDA’s Unique Device Identifier (UDI) database. The U.S. location ensures compliance with FDA standards for device safety, performance, and labeling.
Which regulatory registries list Dentsply De Trey GmbH’s devices?
Dentsply De Trey GmbH’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for dental and endodontic products, allowing healthcare providers, regulators, and stakeholders to verify device details, classifications, and compliance with U.S. regulatory standards.
How are Dentsply De Trey GmbH’s devices classified under FDA regulations?
Dentsply De Trey GmbH’s devices are classified under FDA’s Class I and Class II categories. Class I generally includes low-risk devices like orthodontic pliers, while Class II covers moderate-risk items such as dental composite resins, bonding agents, and endodontic sealers, which require special controls to ensure safety and effectiveness. Classification determines regulatory oversight, labeling requirements, and post-market surveillance.
What kinds of dental materials does Dentsply De Trey GmbH focus on, and why are these important?
Dentsply De Trey GmbH focuses on restorative, bonding, and endodontic materials, including dental composites (for fillings), dentine adhesives (for tooth bonding), and root canal sealers (for infection prevention). These materials are critical in dental procedures because they restore function, improve aesthetics, and ensure long-term tooth integrity. Their formulations—like flowable composites or epoxy resins—are designed for precision application, minimizing patient discomfort and maximizing treatment success.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- dentsplysirona.com
- —
- —
- [email protected]
- Phone
- +498000735000
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 315471722
Catalogue (100)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| TPH Spectra ST | 642231 | FDA UDI | Class II | Active |
| SmartLite Focus | 64450021 | FDA UDI | Class II | Active |
| Automatrix Snippers+ Catch Tray | 62422605 | FDA UDI | Class I | Active |
| TPH Spectra ST | 642542 | FDA UDI | Class II | Active |
| Chemfil Rock | 60606592 | FDA UDI | Class II | Unknown |
| Prime&Bond active | 60667340 | FDA UDI | Class II | Active |
| Smartlite Focus | 64450060 | FDA UDI | Class II | Unknown |
| AH Plus Jet Endodontic Sealer Syringe Refill | 60620118NA | FDA UDI | Class II | Active |
| TPH Spectra ST flow | 642513 | FDA UDI | Class II | Active |
| Ah 26 | 60620002 | FDA UDI | Class II | Active |
| TPH Spectra ST | 642470 | FDA UDI | Class II | Active |
| TPH Spectra ST flow | 642529 | FDA UDI | Class II | Active |
| Ah Plus Jet | 667005 | FDA UDI | Class II | Active |
| TPH Spectra ST | 642224 | FDA UDI | Class II | Active |
| TPH Spectra ST | 642474 | FDA UDI | Class II | Active |
| TPH Spectra ST flow | 642523 | FDA UDI | Class II | Active |
| TPH Spectra ST | 642013 | FDA UDI | Class II | Active |
| TPH Spectra ST | 642233 | FDA UDI | Class II | Active |
| Prime&Bond Xp | 60667401 | FDA UDI | Class II | Active |
| TPH Spectra ST | 642545 | FDA UDI | Class II | Active |
| TPH Spectra ST flow | 642522 | FDA UDI | Class II | Active |
| Chemfil Rock | 60606590 | FDA UDI | Class II | Unknown |
| TPH Spectra ST flow | 642511 | FDA UDI | Class II | Active |
| AH Plus Endodontic Sealer Tubes | 60620110NA | FDA UDI | Class II | Active |
| Prime&Bond active | 60667347 | FDA UDI | Class II | Active |
| TPH Spectra ST | 642221 | FDA UDI | Class II | Active |
| TPH Spectra ST | 642000 | FDA UDI | Class II | Active |
| TPH Spectra ST | 642461 | FDA UDI | Class II | Active |
| Automatrix Snippers+ | 62422601 | FDA UDI | Class I | Active |
| TPH Spectra ST | 642541 | FDA UDI | Class II | Active |
| TPH Spectra ST flow | 642512 | FDA UDI | Class II | Active |
| TPH Spectra ST | 642475 | FDA UDI | Class II | Active |
| Prime&Bond active | 60667342 | FDA UDI | Class II | Active |
| TPH Spectra ST | 642544 | FDA UDI | Class II | Active |
| Prime&Bond active | 60667343 | FDA UDI | Class II | Active |
| TPH Spectra ST | 642223 | FDA UDI | Class II | Active |
| TPH Spectra ST flow | 642514 | FDA UDI | Class II | Active |
| TPH Spectra ST flow | 642510 | FDA UDI | Class II | Active |
| TPH Spectra ST flow | 642519 | FDA UDI | Class II | Active |
| TPH Spectra ST | 642232 | FDA UDI | Class II | Active |
| Prime&Bond active | 60667354 | FDA UDI | Class II | Active |
| TPH Spectra ST | 642005 | FDA UDI | Class II | Active |
| SmartLite Focus | 64450070 | FDA UDI | Class II | Active |
| TPH Spectra ST | 642462 | FDA UDI | Class II | Active |
| Ah Plus Jet | 667007 | FDA UDI | Class II | Active |
| TPH Spectra ST | 642472 | FDA UDI | Class II | Active |
| TPH Spectra ST | 642236 | FDA UDI | Class II | Active |
| TPH Spectra ST | 642471 | FDA UDI | Class II | Active |
| TPH Spectra ST | 642001 | FDA UDI | Class II | Active |
| Chemfil Rock | 60606594 | FDA UDI | Class II | Unknown |
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