Ips 99 One and Ips 99 Ceram
510(k) K121359
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK121359 | Date27 Jul 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- Withdrawn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
- 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 Ceram One and IPS e.max Ceram are lithium disilicate-based ceramic materials designed for dental restorations. These single-layer ceramics are engineered for layering applications, providing natural depth and vividness through oxyapatite crystal composition, which enhances light reflection and aesthetic properties in restorative work.
These materials are supplied as dental ceramics for use in laboratory settings by trained professionals. They are intended for single-use per restoration and are not sterilised for reuse. The devices are authorised under FDA 510(k) clearance (K121359) as substantially equivalent to a predicate device, classified under product code EIH (Dental Ceramics). No additional regulatory status beyond the stated clearance is implied.
From the manufacturer
As a single-layer ceramic, IPS Style Ceram One offers a suitable option for quick and uncomplicated layering, depending on the respective patient requirements. ials.
IPS Style ® Ceram is unique, owed to the exceptional composition of this metal-ceramic material. It is the first material in the history of dental ceramics to contain oxyapatite crystals. These crystals impart your restorations with a true-to-nature depth effect and, thanks to their remarkable light reflection properties, an unmatched vividness from within.
Other devices from Ivoclar Vivadent AG
Questions
AI-generated answers, 18 Sep 2026
Are these materials suitable for use in chairside dental restorations, or are they strictly for laboratory settings?
These materials, IPS e.max Ceram One and IPS e.max Ceram, are explicitly designed for use in laboratory settings only by trained dental professionals. The manufacturer’s description emphasizes their intended application in a controlled lab environment, where precision and specialized equipment are available for dental restorations. Chairside use is not mentioned or implied in the provided data.
How many times can each block or unit of IPS e.max Ceram be used before it needs to be replaced?
The IPS e.max Ceram and IPS e.max Ceram One are single-use per restoration. This means each block or unit is intended for one specific dental restoration and should not be reused or reprocessed for another application, as the manufacturer’s description explicitly states they are ‘not sterilised for reuse.’
What distinguishes the aesthetic properties of these ceramics compared to other lithium disilicate materials?
The IPS e.max Ceram and IPS e.max Ceram One are engineered with oxyapatite crystal composition, which enhances light reflection and depth, resulting in more natural and vivid aesthetics for dental restorations. This composition is specifically highlighted as a key feature for achieving lifelike depth and realism in layering applications, differentiating them from other lithium disilicate ceramics.
Are these materials pre-sterilized, or do they require additional sterilization before use?
The IPS e.max Ceram and IPS e.max Ceram One are not pre-sterilized for reuse. They are supplied for single-use per restoration, meaning they do not undergo sterilization processes intended for reprocessing. The manufacturer’s description clarifies they are intended for one-time use in laboratory settings, so no additional sterilization is required or recommended.