Ivoclar North America, Inc.
United StatesFDA applicant, unverified
- Devices
- 133
What Ivoclar North America, Inc. makes
Ivoclar North America, Inc. manufactures dental materials, including light-curing temporary filling composites (e.g., Fermit N), calcium hydroxide liners for pulp protection, and fluoride-releasing protective agents (e.g., Fluor Protector). The company also produces adhesive and restorative systems like the Tetric Flow composite and the SR-Isosit Spectra Link bonding system, as well as universal dental adhesives (e.g., BioUniversal PDF). Additional offerings include chroma-matched restorative sealants (e.g., HelioSEAL Clear Chroma) and diagnostic tools such as the SPECTRAMAT shade-matching system.
These devices are regulated under the FDA’s 510(k) pathway, with most classified as Class I or Class II. The portfolio is listed in the FDA’s 510(k) database, reflecting their compliance with U.S. medical device regulations. The manufacturer operates from its U.S. headquarters in Amherst, NY.
Catalogue
Search and filter all 133 devicesShowing 1-50 of 133
Frequently asked questions
How many devices does Ivoclar North America, Inc. have in the registry?
The registry currently lists 133 devices for Ivoclar North America, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ivoclar North America, Inc.'s devices?
Among its 50 most recently registered devices, Ivoclar North America, Inc. has devices listed in FDA 510(k) (50 devices).
What risk classes do Ivoclar North America, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Ivoclar North America, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ivoclar North America, Inc. in the registry?
The most recently registered devices listed for Ivoclar North America, Inc. include D-SIGN VI (R&D PROJECT DW266#9), BIOUNIVERSAL PDF, FERMIT N PLUS and TETRIC FLOW.