IPS e.max CAD Abutment Solutions Extra Systems
510(k) K191382
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK191382 | Date26 Aug 2019 | 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- Withdrawn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 Extra Systems are dental abutments designed for computer-aided design and manufacturing (CAD/CAM) workflows. These components are intended for use in dental restorations, providing a structural foundation for crowns, bridges, or other prosthetic attachments in implant dentistry.
Supplied as a reusable, non-sterile system, these abutments are intended for use in dental laboratories or clinics equipped with CAD/CAM technology. The product is authorised under FDA 510(k) clearance (K191382) as substantially equivalent to a predicate device, adhering to dental regulatory standards. Storage and handling follow standard dental practice protocols for non-sterile components.
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.
IPS e.max System IPS e.max combines beauty with high performance in the most impressive way, as it is comprised of materials that demonstrate exceptional life-like esthetics along with fracture resilient toughness. These versatile materials are available for both press and CAD/CAM applications. The decision to use IPS e.max unlocks unlimited opportunities to provide the outcomes patients deserve.
Other devices from Ivoclar Vivadent AG
Questions
AI-generated answers, 18 Sep 2026
Are these abutments meant for single-use or can they be reused in multiple procedures?
The IPS e.max CAD Abutment Solutions are designed as a reusable system, not for single-use. Since they are supplied non-sterile, they must be sterilized between uses following standard dental laboratory or clinical protocols for reusable dental components. This aligns with their intended use in CAD/CAM workflows where components are cleaned, sterilized, and reused for multiple restorations.
What types of dental restorations can these abutments support, and how do they integrate with CAD/CAM technology?
These abutments serve as the structural foundation for crowns, bridges, or other prosthetic attachments in implant dentistry. They are specifically designed for computer-aided design and manufacturing (CAD/CAM) workflows, meaning they are engineered to be scanned, digitally designed, and milled or printed to precise specifications before being used in restorative procedures. The system enables precise fitting and customization for individual patient needs.
How should these abutments be stored, and are there any special handling requirements?
The IPS e.max CAD Abutment Solutions are supplied non-sterile, so storage follows standard dental practice protocols for non-sterile components. They should be kept in a clean, dry environment, protected from contamination, and handled in accordance with dental laboratory or clinical hygiene guidelines. Before use, they must be sterilized as part of the reusable workflow. No additional special handling requirements are specified beyond typical dental component preparation.
What regulatory pathway was followed for this device, and what does that mean for its use in clinical settings?
The device was cleared through the FDA 510(k) process (K191382), specifically under an Abbreviated 510(k) pathway with a determination of Substantially Equivalent (SESE) to a predicate device. This means the FDA reviewed it as a modification or improvement of an existing, legally marketed dental abutment and found it to meet the same regulatory standards. Clinically, this clearance indicates the device adheres to dental safety and performance requirements, but practitioners should always follow their local guidelines and manufacturer instructions for proper use.