IPS E.max Press Abutment Solutions
510(k) K120053
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK120053 | Date18 Oct 2012 | 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- Withdrawn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 Press Abutment Solutions is a lithium disilicate glass-ceramic ingot (LS2) designed for dental press-ceramic restorations. It provides high strength (470 MPa) and is intended for fabricating veneers, crowns, and hybrid abutment solutions, including single-tooth restorations in both anterior and posterior regions.
These abutment solutions are supplied as a dental press-ceramic material for use in fixed restorative procedures. They are intended for single-tooth restorations up to the second premolar as the distal abutment, with no explicit sterility or single-use/reusable designation noted. The device holds an FDA 510(k) clearance under product code NHA, classified under the Dental advisory committee.
From the manufacturer
The ideal combination of fit, form and function - that's what press-ceramics are known for. Thanks to their strength of 470 MPa, IPS e.max Press can be used for the fabrication of veneers, crowns and 3-unit bridges [1] and also for hybrid abutment solutions involving single-tooth restorations in the anterior and posterior region.
Heintze S, Clinical efficacy of monolithic crowns made of IPS e.max Press on posterior teeth, Test Report, Ivoclar Vivadent, 2021.
Other devices from Ivoclar Vivadent AG
Questions
AI-generated answers, 18 Sep 2026
What types of dental restorations can the IPS E.MAX Press Abutment Solutions be used for, and where in the mouth are they suitable?
The IPS E.MAX Press Abutment Solutions are designed for fabricating veneers, crowns, and hybrid abutment solutions using lithium disilicate glass-ceramic (LS2) technology. They are specifically intended for single-tooth restorations in both anterior (front) and posterior (back) regions, though they are limited to use as the distal abutment up to the second premolar.
Is the IPS E.MAX Press Abutment Solutions intended for single-use or can it be reused?
The provided data does not explicitly state whether the IPS E.MAX Press Abutment Solutions are single-use or reusable. Clinicians should follow standard dental material handling protocols based on their practice and manufacturer guidelines, as no sterility designation or reuse instructions are mentioned.
How is the IPS E.MAX Press Abutment Solutions supplied, and what are its key material properties?
The IPS E.MAX Press Abutment Solutions are supplied as a lithium disilicate glass-ceramic ingot (LS2) intended for dental press-ceramic restorations. It offers high strength, with a specified compressive strength of 470 MPa, making it suitable for durable restorations like veneers, crowns, and hybrid abutments.
What regulatory pathway was followed for FDA clearance of the IPS E.MAX Press Abutment Solutions?
The IPS E.MAX Press Abutment Solutions received FDA clearance through a traditional 510(k) process, classified under product code NHA and reviewed by the Dental (DE) Advisory Committee. The clearance was granted on October 18, 2012, with a decision code indicating substantial equivalence (SESE).