IPS Ivocolor

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K151894 ↗

FDA product code

EIH

FDA applicant

Ivoclar Vivadent, AG

Device class

Class II

Regulation

21 CFR Part 872.6660

Advisory committee

Dental

FDA decision

SESE Substantially Equivalent

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See all devices from Ivoclar Vivadent AG →

• What types of dental restorations can IPS Ivocolor be used on, and why is this important for my practice?

  IPS Ivocolor is designed for use on ceramic restorations made from press, CAD, or layering ceramics, including those from Ivoclar Vivadent and zirconium oxides from Wieland Dental. This versatility is important because it ensures compatibility across different ceramic systems, allowing for consistent staining and glazing regardless of the material’s coefficient of thermal expansion (CTE). This helps achieve a uniform aesthetic appearance in your restorations, reducing the risk of mismatched colors or textures.

• Is IPS Ivocolor intended for use in dental laboratories or clinics, and how is it supplied?

  IPS Ivocolor is supplied as a multi-component system specifically for use in dental laboratories and clinics. It is not sterile at the point of supply, meaning it requires preparation and application in a controlled environment before use on ceramic restorations. This makes it suitable for in-office or lab-based procedures where proper handling and sterilization of the final restoration are maintained.

• Are the materials in IPS Ivocolor meant for single-use or can they be reused?

  The materials in IPS Ivocolor are intended for single-use applications on ceramic restorations. This design ensures consistency in staining and glazing results, as reuse could compromise the material’s integrity or introduce contamination, potentially affecting the final aesthetic outcome of the restoration.

• What regulatory pathway does IPS Ivocolor follow, and how does this impact its use in the U.S.?

  IPS Ivocolor follows the FDA’s 510(k) clearance pathway, specifically under the traditional route with clearance number K151894. This means it has been determined to be substantially equivalent to a legally marketed device and is authorized for use in the U.S. under the applicable product code (EIH) for dental materials. Clinicians and laboratories can rely on this clearance to ensure compliance with U.S. regulatory standards.

• How should I store IPS Ivocolor, and what storage conditions are recommended?

  While the exact storage conditions are governed by Ivoclar Vivadent’s specifications, the manufacturer’s guidelines typically recommend storing IPS Ivocolor in a cool, dry place, away from direct sunlight and extreme temperatures. Proper storage is critical to maintaining the material’s performance and ensuring the integrity of the staining and glazing properties for consistent results in your restorations.