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Sign in to claim this brandIvoclar Vivadent, Inc.
US
Last updated September 17, 2026
What Ivoclar Vivadent, Inc. makes
Ivoclar Vivadent, Inc. manufactures dental materials and devices for restorative and impression procedures, including noble and non-noble casting alloys, dental amalgams, single-use and reusable impression trays, silicone and alginate impression materials, and bite verification devices for dental prostheses.
The company’s portfolio includes Class I and Class II devices, with products authorised via FDA 510(k) clearances and FDA UDI registrations. These devices are listed under the FDA regulatory framework, and the company 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 Ivoclar Vivadent, Inc. manufacture?
Ivoclar Vivadent, Inc. specializes in dental devices primarily used in restorative and impression procedures. Their portfolio includes dental casting alloys (both noble and non-noble), dental amalgams, single-use and reusable impression trays, silicone and alginate impression materials, and bite verification devices for dental prostheses. These products are designed to support dental practitioners in creating precise restorations and impressions for patient care.
Where is Ivoclar Vivadent, Inc. based, and what does that mean for their regulatory oversight?
Ivoclar Vivadent, Inc. is based in the United States, which means their devices fall under the jurisdiction of the FDA (U.S. Food and Drug Administration). Since their products are dental devices, they are classified under FDA regulations, including 510(k) clearances for premarket submissions and UDI (Unique Device Identification) registrations to ensure traceability and compliance with U.S. medical device laws.
Which regulatory registries or databases list Ivoclar Vivadent, Inc.’s devices?
Ivoclar Vivadent, Inc.’s devices are listed in the FDA’s 510(k) clearance database and the FDA’s UDI (Unique Device Identification) registry. These registries ensure transparency and compliance by documenting the premarket submissions and identifying details of their authorised devices, which helps healthcare providers and regulators verify product authorisation status.
How are Ivoclar Vivadent, Inc.’s dental devices classified under FDA regulations?
Ivoclar Vivadent, Inc.’s devices are classified as either Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher risk and require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway, such as 510(k) clearance requirements, ensuring appropriate oversight based on the device’s risk level.
What does it mean for Ivoclar Vivadent, Inc.’s devices to be authorised via FDA 510(k) clearances?
An FDA 510(k) clearance means that Ivoclar Vivadent, Inc.’s devices have been determined to be substantially equivalent to a legally marketed predicate device—that is, a previously authorised product with similar intended use and technology. This process ensures that the new device meets the same safety and performance standards as its predecessor, allowing it to enter the U.S. market legally without requiring the more rigorous premarket approval (PMA) process.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 175 PINEVIEW DR., AMHERST, NY, 14228
- Website
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- Phone
- —
- PRRC Contact
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- EUDAMED SRN
- —
- FDA FEI Number
- 1316092
- DUNS Number
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Catalogue (608)
Page 2 of 13| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Capricorn | 577349 | FDA UDI | Class II | Active |
| MidiGold 54 | 583046 | FDA UDI | Class II | Active |
| Virtual XD | 646449 | FDA UDI | Class II | Unknown |
| BioUniversal E | 592537 | FDA UDI | Class II | Unknown |
| Maxigold KF | 576631 | FDA UDI | Class II | Active |
| Harmony KF | 582011 | FDA UDI | Class II | Unknown |
| Solarcast 20 | 582207 | FDA UDI | Class II | Active |
| d SIGN 98 | 580320 | FDA UDI | Class II | Active |
| Capricorn | 579894 | FDA UDI | Class II | Active |
| Valiant | NA6050141 | FDA UDI | Class II | Unknown |
| Academy Gold XH | 579793 | FDA UDI | Class II | Unknown |
| L C B Y .3mm Spool | 584139 | FDA UDI | Class II | Unknown |
| W 5 | 584045 | FDA UDI | Class II | Unknown |
| Lcy .3mm Spool | 584136 | FDA UDI | Class II | Unknown |
| Valiant | NA6050420 | FDA UDI | Class II | Active |
| Harmony C B 55 | 582219 | FDA UDI | Class II | Active |
| BioUniversal PKF | 579874 | FDA UDI | Class II | Unknown |
| Lodestar | 582042 | FDA UDI | Class II | Active |
| Laser C B White | NA1194904 | FDA UDI | Class II | Unknown |
| Magenta | 582121 | FDA UDI | Class II | Active |
| Callisto Implant 33 | 638937 | FDA UDI | Class II | Active |
| Aquarius Hard | 576618 | FDA UDI | Class II | Active |
| Aquarius XH | 584072 | FDA UDI | Class II | Unknown |
| Virtual XD | 646457 | FDA UDI | Class II | Unknown |
| Harmony XH | 582027 | FDA UDI | Class II | Active |
| Magenta | 584094 | FDA UDI | Class II | Unknown |
| Virtual XD | 646435 | FDA UDI | Class II | Unknown |
| Universal Solder PKF | 573373 | FDA UDI | Class II | Active |
| Hfyc Sdr 1.55 | 584116 | FDA UDI | Class II | Unknown |
| Harmony 2 | 643607 | FDA UDI | Class II | Active |
| Brite Gold XH | 591352 | FDA UDI | Class II | Unknown |
| Evolution Lite | 583653 | FDA UDI | Class II | Active |
| Virtual XD | 646466 | FDA UDI | Class II | Unknown |
| Brite Gold XH | 591348 | FDA UDI | Class II | Unknown |
| Virtual | 562853AN | FDA UDI | Class II | Unknown |
| Protocol | 582989 | FDA UDI | Class II | Unknown |
| Virtual XD | 646448 | FDA UDI | Class II | Active |
| Spartan Plus | 584070 | FDA UDI | Class II | Unknown |
| BioUniversal KGF plus | 681846 | FDA UDI | Class II | Unknown |
| Brite Gold | 579886 | FDA UDI | Class II | Active |
| Brite Gold XH | 591349 | FDA UDI | Class II | Unknown |
| Virtual | 562854AN | FDA UDI | Class II | Unknown |
| Laser C B Yellow | NA1194504 | FDA UDI | Class II | Unknown |
| Callisto Implant 33 | 638938 | FDA UDI | Class II | Active |
| Accudent Xd | 673713 | FDA UDI | Class I | Active |
| Harmony PF | 576600 | FDA UDI | Class II | Unknown |
| Telio CAD | 682038 | FDA UDI | Class II | Unknown |
| BioUniversal E | 592529 | FDA UDI | Class II | Unknown |
| d SIGN 53 | 579902 | FDA UDI | Class II | Active |
| Golden Ceramic | NA1191004 | FDA UDI | Class II | Unknown |
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