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Sign in to claim this brandCandulor AG
US
Last updated May 23, 2026
What Candulor AG makes
Candulor AG manufactures dental materials used in prosthetic and orthodontic applications, including resin-based artificial teeth, denture base resins, dental appliance fabrication resins, and custom dental impression tray materials. Their product line includes kits and specialized resins designed for precision fitting and durability in dental prosthetics, such as removable dentures and orthodontic appliances.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. Candulor AG operates from the United States, adhering to regulatory requirements for dental materials and prosthetics in that jurisdiction.
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 Candulor AG manufacture?
Candulor AG specializes in dental materials used primarily for prosthetic and orthodontic applications. Their product line includes resin-based artificial teeth, denture base resin kits, dental appliance fabrication materials, and custom dental impression tray materials. These materials are designed for precision fitting and durability in dental prosthetics, such as removable dentures and orthodontic appliances.
Where is Candulor AG based, and what regulatory jurisdiction does it operate under?
Candulor AG is based in the United States. As a manufacturer, it operates under the regulatory requirements of the FDA, ensuring its dental materials comply with U.S. standards for safety, performance, and quality in prosthetic and orthodontic applications.
Which regulatory registries or databases list Candulor AG’s devices?
Candulor AG’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the U.S., ensuring transparency and traceability for healthcare providers and regulators.
How are Candulor AG’s devices classified under FDA regulations?
Candulor AG’s devices fall under FDA’s Class I and Class II classifications. Class I devices generally pose minimal risk and require less regulatory oversight, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body area it interacts with.
What is the primary purpose of the dental materials produced by Candulor AG?
The primary purpose of Candulor AG’s dental materials is to support the fabrication of durable, well-fitting dental prosthetics and orthodontic appliances. Their resin-based products, such as artificial teeth and denture base resins, are engineered to provide stability, longevity, and a natural appearance in restorative dental work, ensuring patient comfort and functionality.
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
- 480467422
Catalogue (6988)
Page 139 of 140| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| PHYSIOSTAR NFCplus | 661201 | FDA UDI | Class II | Active |
| BONARTIC II NFCplus | 643050 | FDA UDI | Class II | Active |
| Candulor TCR | 552608 | FDA UDI | Class II | Active |
| Candulor Preference | 578527 | FDA UDI | Class II | Active |
| PHYSIOSTAR NFCplus | 661052 | FDA UDI | Class II | Active |
| BONARTIC II NFCplus | 660161 | FDA UDI | Class II | Active |
| Candulor TCR | 552769 | FDA UDI | Class II | Active |
| Candulor TCR | 697017 | FDA UDI | Class II | Active |
| Candulor TCR | 696928 | FDA UDI | Class II | Active |
| Preference | 578638 | FDA UDI | Class II | Active |
| Preference | 578557 | FDA UDI | Class II | Active |
| Candulor TCR | 698611 | FDA UDI | Class II | Active |
| PhysioSelect TCR | 696719 | FDA UDI | Class II | Active |
| Physioset TCR 6er | 552225 | FDA UDI | Class II | Active |
| Bonartic TCR 8er | 600592 | FDA UDI | Class II | Active |
| BONARTIC II NFCplus | 660107 | FDA UDI | Class II | Active |
| Preference | 578593 | FDA UDI | Class II | Active |
| Preference | 578718 | FDA UDI | Class II | Active |
| Physioset TCR 6er | 600449 | FDA UDI | Class II | Active |
| Bonartic TCR 8er | 600618 | FDA UDI | Class II | Active |
| Bonartic TCR 8er | 600561 | FDA UDI | Class II | Active |
| Bonartic TCR 8er | 600608 | FDA UDI | Class II | Active |
| Candulor Preference | 578434 | FDA UDI | Class II | Active |
| Candulor TCR | 600559 | FDA UDI | Class II | Active |
| Physioset TCR 6er | 552642 | FDA UDI | Class II | Active |
| PHYSIOSTAR NFCplus | 661344 | FDA UDI | Class II | Active |
| PhysioSelect TCR | 696947 | FDA UDI | Class II | Active |
| PHYSIOSTAR NFCplus | 661280 | FDA UDI | Class II | Active |
| Physioset TCR 6er | 552740 | FDA UDI | Class II | Active |
| Candulor TCR | 552681 | FDA UDI | Class II | Active |
| Candulor TCR | 552872 | FDA UDI | Class II | Active |
| PHYSIOSTAR NFCplus | 661162 | FDA UDI | Class II | Active |
| Bonartic TCR 8er | 600648 | FDA UDI | Class II | Active |
| Physioset TCR 6er | 600486 | FDA UDI | Class II | Active |
| Candulor TCR | 600524 | FDA UDI | Class II | Active |
| Candulor TCR | 696917 | FDA UDI | Class II | Active |
| Preference | 578566 | FDA UDI | Class II | Active |
| PhysioSelect TCR | 696987 | FDA UDI | Class II | Active |
| Candulor Preference | 578644 | FDA UDI | Class II | Active |
| Candulor TCR | 600582 | FDA UDI | Class II | Active |
| Candulor TCR | 552638 | FDA UDI | Class II | Active |
| PhysioSelect TCR | 696768 | FDA UDI | Class II | Active |
| BONARTIC II NFCplus | 643055 | FDA UDI | Class II | Active |
| BONARTIC II NFCplus | 660146 | FDA UDI | Class II | Active |
| PHYSIOSTAR NFCplus | 641192 | FDA UDI | Class II | Active |
| PhysioSelect TCR | 697092 | FDA UDI | Class II | Active |
| BONARTIC II NFCplus | 660200 | FDA UDI | Class II | Active |
| Preference | 578464 | FDA UDI | Class II | Active |
| Candulor TCR | 616553 | FDA UDI | Class II | Active |
| Physioset Ct | 547579 | FDA UDI | Class II | Unknown |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Candulor, Ag Glattpark Zurich · CH FEI 1000277456