IPS e.max One

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

510(k) Number

K211916 ↗

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

• Adhese 2 Refill VivaPen 1x0.5ml

  Class IIa

  CE/MDR

• Ivocryl X 8 A-D IUK30 A3

  Class IIa

  CE/MDR

• IPS e.max Ceram Art Illus & Structu Asso

  Class IIa

  CE/MDR

• Ivostar 6er A-D China O32 B2

  Class IIa

  CE/MDR

• Ivostar Juego de 6 A-D China S33 C4

  Class IIa

  CE/MDR

• Ivostar Set of 6 U44 01

  Class IIa

  CE/MDR

See all devices from Ivoclar Vivadent AG →

• What types of dental restorations can the IPS e.max One material be used to create, and how does it differ from other ceramic materials in terms of application?

  The IPS e.max One is specifically designed for creating all-ceramic restorations such as crowns, inlays, onlays, and veneers using CAD/CAM technology. Unlike some other ceramic materials, it is formulated to provide both high esthetic performance—meaning it closely mimics the natural appearance of teeth—and mechanical strength, making it suitable for procedures where durability and lifelike aesthetics are essential. Its composition supports precise milling and sintering, ensuring a tight fit and natural-looking results.

• Is the IPS e.max One block sterile when received, and how should it be handled in the dental laboratory before use?

  The IPS e.max One blocks are supplied in a non-sterile form, intended exclusively for dental laboratory use. They must be prepared and processed by trained dental technicians before clinical application. Since they are designed for single-use per restoration, each block is milled into a custom restoration, which is then sterilized for patient use following standard dental protocols.

• What sizes or models of the IPS e.max One are available, and how do they relate to CAD/CAM systems?

  The IPS e.max One is distributed in various sizes tailored for CAD/CAM systems, though the exact dimensions or model variants are not specified in the provided data. These sizes are designed to accommodate different milling machines and workflows, ensuring compatibility with standard dental laboratory equipment. Buyers should refer to the manufacturer’s documentation for precise size options and system requirements.

• How should the IPS e.max One material be stored to ensure it remains effective for milling and fabrication?

  While the exact storage instructions aren’t detailed in the provided data, the manufacturer recommends following standard guidelines to maintain material integrity. Typically, ceramic blocks like this should be stored in a clean, dry environment away from extreme temperatures or humidity to prevent degradation before use. Always consult Ivoclar Vivadent’s official documentation for the most up-to-date storage protocols.

• What regulatory pathway does the IPS e.max One follow, and how does this affect its use in clinical settings?

  The IPS e.max One is regulated under the FDA 510(k) clearance process (K211916) and is classified as substantially equivalent to a predicate device. This means it has undergone review by the FDA’s Dental Advisory Committee (DE) and is approved for use in dental restorative procedures in the U.S. Clinicians and laboratories can proceed with confidence, knowing the material meets FDA standards for safety and effectiveness as a dental ceramic material.