Estetic Ceram AG · Class II · Cleared Jun 5, 2025
| K-number | K251084 |
| Device name | zirkon; structure; LFU shades, stains and glazes |
| Applicant | Estetic Ceram AG |
| Product code | EIH |
| Device class | Class II |
| Decision date | Jun 5, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 872.6660 |
zirkon; structure; LFU shades, stains and glazes is a zirconia layering porcelain system consisting of ceramic powders and pastes used by dental technicians in laboratories to create dental restorations. It is intended for anterior and posterior crowns, veneers, inlays, and onlays.
The subject device is silicate glass ceramic powder or paste with main constituents SiO2, Al2O3, K2O, Na2O, Li2O, and B2O3. It is classified as Type 1, Class 1b per ISO 6872:2019. The predicate device (Soprano 10/Soprano Surface/Soprano) has similar physical form, material composition with comparable silicate glass ceramic constituents, and identical classification.
ISO 6872:2015 (dental ceramics), ISO 7405:2018 (biocompatibility testing), and ISO 10993:2018 (biological evaluation of medical devices). Performance testing measured flexural strength, chemical solubility, coefficient of thermal expansion, glass transition temperature, and radioactivity of 238U.
Substantial equivalence is established because the subject device and predicate devices share identical intended uses (same restoration types), same physical state (powder/paste), comparable silicate glass ceramic compositions with nearly identical elemental constituents, and matching ISO 6872:2019 classification. Both are surface-contacting materials with permanent oral mucosal contact, and the subject device meets the same performance standards (ISO 6872:2015) and biocompatibility requirements as the predicate.
View the full FDA submission: accessdata.fda.gov