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Ivoclar North America, Inc.

Also registered as Invoclar 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.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue133

Newest first, rows 101-133 of 133

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  • Targis Alloy #7 Ref K970963

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Variolink Ii Ref K971372

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Midigold 50 Ref K905322

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Stainless Steel Dental Wires And Clasps Ref K901024

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Dw 272 #1 Ref K003634

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Gnathomat Articulator Ref K896131

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Special Bond Ref K901916

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Monopaque Ref K990315

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • R&D Project DW269#25 Ref K001469

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • DW207 #28G, DW207 #35F, DW207 #39LC Ref K931365

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Eos Impression Trays Ref K896470

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Will-Ceram W Ref K905329

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Helio Progress (Dental Composite) Ref K901914

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ips Empress Ref K913372

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Sr-Ivocap Ref K896130

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Dw 235 Ref K905205

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Harmony Line Pf Ref K950517

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Wlw Ref K905320

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ariston Phc Liner Ref K981335

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Variolink Ref K931309

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Dual Cement Ref K901917

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Modification To Excite Ref K011490

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • X-L And X-Lx Ref K905325

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Sonicsys Inlay Ref K972648

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • D-Sign V (R&D Project DW267#17) Ref K990182

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Sr Spectrasit, Sr Chromasit Ref K930128

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Vivalux Ref K926556

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Dw 273 #1 Ref K003632

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • R&D Project DW271#11A Ref K002872

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Sr-Ivoseal Ref K896139

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Tetric Ceram Ref K964285

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • DW238 #228-34A Ref K913068

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Concept Inlay/Onlay Ref K901396

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 101-133 of 133

Showing 101-133 of 133