IPS E.Max Press Multi
510(k) K120134
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK120134 | Date25 Jun 2012 | StatusActive |
Official records
- FDA 510(k) database K120134
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- 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
Overview
AI-generated summary, 18 Sep 2026
The IPS E.Max Press Multi is a glass-ceramic ingot insert designed for dental restorations, specifically for fabricating crowns and other restorative structures using a press-molding technique. It is part of the IPS e.max Press system, which utilizes lithium disilicate glass-ceramic for high-strength, esthetically pleasing dental restorations.
This device is supplied as a multi-ingot insert, enabling the fabrication of up to four crowns or multiple restorations in a single press cycle. It is intended for use in dental laboratories and is not sterile at time of shipment, requiring preparation and processing before clinical application. The device is regulated under the FDA’s 510(k) clearance process, classified under product code EIH (Dental, Restorative, Crowns, Bridges, Inlays, Onlays, and Veneers).
From the manufacturer
IPS e.max Press pays off, allowing up to 4 IPS e.max Press Multi crowns or, depending on the restoration type, 6 -12 IPS e.max Press restorations to be fabricated in a single press cycle.