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
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