(158 days)
INNI-CERA is indicated for use by dental technicians in the construction of custom made all ceramic restorations.
Coping
Crown
Inlay & Onlay
Veneer
Bridge(3-unit anterior bridges)
INNI-CERA is intended for use in fabricating custom-made ceramic restorations using a 3D printer additive manufacturing process. It is a product that is used after fabricating and sintering with a mixture of zirconia powder and binder. The DLP 3D printer used to fabricate the INNICERA is a photocuring lamination method using an STL file (dental restoration shape), which is irradiated with light in the strong UV region (420nm) to cure the photocurable mixture to form a model. This product corresponds to ISO 6872 Type I Class III. The material is used in a 3D printer, which prints the shape determined by an STL file converted from patients' teeth data. 3D printer is not included with the product. INNI-CERA cannot be reused.
The provided text describes a 510(k) premarket notification for a dental material, INNI-CERA. The submission focuses on demonstrating substantial equivalence to a predicate device, not on proving device performance against acceptance criteria in a typical clinical study with human readers or AI.
Therefore, many of the requested categories for acceptance criteria and study details are not applicable in this context. The document primarily describes bench testing to ensure the material meets established standards for dental ceramics.
Here's a breakdown of the applicable information:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (ISO 6872 requirements) | Reported Device Performance (INNI-CERA) |
|---|---|---|
| Flexural Strength | >300 MPa | >300 MPa |
| Chemical Solubility |
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.