IPS E.max CAD Abutment Solutions
510(k) K132209
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK132209 | Date31 Oct 2013 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- NHA
- FDA applicant
- Ivoclar Vivadent, AG
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3630
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The IPS E.max CAD Abutment Solutions are implant-supported abutments fabricated from lithium disilicate glass-ceramic, designed for single-tooth restorations. These abutments are engineered for use in computer-aided design and manufacturing (CAD/CAM) workflows, providing a monolithic structure for hybrid restorations in dental implantology.
These abutments are supplied as a sterile, single-use component intended for dental professionals in clinical settings. They are compatible with various CAD/CAM systems and are regulated under an FDA 510(k) clearance (K132209) as substantially equivalent to a predicate device. No additional sterilization or reuse is required, and their use adheres to dental implant restoration protocols.
From the manufacturer
Discover IPS e.max CAD - the original lithium disilicate glass-ceramic material for CAD/CAM fabrication. Clinically proven, esthetic and efficient in everyday practice.
The offering varies, depending on the CAD/CAM system being used. [8] The survival rate of monolithic IPS e.max CAD posterior crowns was evaluated with the Kaplan-Meier method. The failure rate refers to technical failures such as fractures and chipping, R&D Ivoclar, Schaan.
Other devices from Ivoclar Vivadent AG
Questions
AI-generated answers, 18 Sep 2026
What types of dental restorations are these abutments designed for, and why is the lithium disilicate material important in this context?
The IPS E.max CAD Abutment Solutions are specifically designed for single-tooth implant-supported restorations using a CAD/CAM workflow. The lithium disilicate glass-ceramic material is chosen for its strength, aesthetic properties, and biocompatibility, making it ideal for hybrid restorations where durability and natural appearance are critical. This material also allows for monolithic fabrication, reducing the need for additional layers or veneers while maintaining structural integrity.
Are these abutments meant to be reused, or are they intended for single-use only? What does that mean for clinical workflows?
These abutments are sterile and intended for single-use only, meaning each one is packaged for one-time clinical application. This eliminates the need for additional sterilization steps, simplifying workflows and reducing the risk of cross-contamination. Clinicians can rely on their pre-sterilized condition, ensuring safety and consistency in implant-supported restorations.
How do I know if these abutments are compatible with my dental lab’s CAD/CAM system?
The IPS E.max CAD Abutment Solutions are engineered for compatibility with various CAD/CAM systems, though exact integration depends on your lab’s specific software and hardware. Ivoclar Vivadent typically provides technical support or documentation outlining supported systems, so checking their resources or contacting their customer service would confirm compatibility. Their design prioritizes versatility within dental implantology workflows.
Do these abutments require any special storage conditions, and if so, why?
While the exact storage instructions aren’t detailed here, most sterile single-use dental components like these abutments should be stored in a cool, dry place away from direct sunlight to preserve sterility and material integrity. Lithium disilicate glass-ceramic is sensitive to extreme temperatures or humidity, so proper storage ensures the abutments remain free from contamination and maintain their structural properties until use.