(130 days)
Dental Lithium Disilicate Glass-Ceramic is available using CAD/CAM and hot pressing techniques for the preparation of full ceramic crowns, inlays, onlays, veneer and full ceramic 3-unit anterior bridges.
Dental Lithium Disilicate Glass-Ceramic is a lithium disilicate ceramic to be supplied in the form of cuboid and cylinder. Dental Lithium Disilicate Glass-Ceramic can be fabricated using CAD/CAM and hot pressing technologies. The device is a glass type material used for aesthetic purposes of full ceramic crowns, inlays, onlays, veneer and full ceramic 3-unit anterior bridges. The ceramics material is composed of SiO2, Li2O, K2O, Al2O3, P2O5, ZrO2 and other oxides. It contains inorganic pigments. The inorganic pigments generate the color on the restorations, after sintering at dental labs, that matches natural color of patient's teeth. The performance of the device conforms to ISO 6872:2015 Dentistry: Ceramic Materials. It is a single-use device, and provided non-sterile.
This document is a 510(k) summary for a dental material, not an AI/ML medical device. Therefore, the questions related to AI/ML device performance, such as sample size for test sets, data provenance, ground truth establishment, expert adjudication, MRMC studies, and standalone performance, are not applicable.
The document describes the acceptance criteria for the Dental Lithium Disilicate Glass-Ceramic device and the non-clinical testing performed to demonstrate its compliance.
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1. A table of acceptance criteria and the reported device performance
The document provides a comparison table (Table 1) that includes several parameters which act as acceptance criteria derived primarily from the ISO 6872:2015 standard for ceramic materials. The "New Device" column shows the reported device performance.
| Parameters | Acceptance Criteria (New Device Performance) | Predicate Device A (IPS E.MAX CAD) | Predicate Device B (Glass Ceramics) | Remarks (Comparison to Predicates) |
|---|---|---|---|---|
| Product Code | EIH | EIH | EIH | Same |
| Regulation No. | 21 CFR 872.6660 | 21 CFR 872.6660 | 21 CFR 872.6660 | Same |
| Class | 2 | 2 | 2 | Same |
| Intended use | For preparation of full ceramic crowns, inlays, onlays, veneer and full ceramic 3-unit anterior bridges. | Similar indications, specifically for CAD/CAM machinable glass ceramic. | Similar indications, including veneers, inlay/onlay, partial crowns, anterior/posterior crowns (hot press or CAD/CAM). | Similar |
| Material | $SiO_2$, $Li_2O$, $K_2O$, $Al_2O_3$, $P_2O_5$, $ZrO_2$ and other oxides | $SiO_2$, $Li_2O$, $K_2O$, $P_2O_5$, $ZrO_2$, $ZnO$ and other oxides | $SiO_2$, $Li_2O$, $K_2O$, $Al_2O_3$ and other oxides | Similar |
| Environment of use | Prescription Use | Prescription Use | Prescription Use | Same |
| Design | Cuboid, Cylinder | Block | Block | Similar |
| Color (Translucency) | HT, MT, LT, MO, HO | HT, LT, MO | Various (not publicly available for Predicate B) | Similar (New device offers more options than Predicate A) |
| Color (Shades) | HT/MT/LT: 16 A-D and 4 Bleach; MO: 5 MO 0 – MO 4; HO: 3 HO 0– HO 2 | HT/LT: 16 A-D and 4 Bleach; MO: 5 MO 0 – MO 4 | Not publicly available | Similar |
| Crystallization State | Cuboid: Partially crystallized; Cylinder: Fully crystallized | Partially crystallized | Not specified for Predicate B | Similar (Predicate A has only partially crystallized) |
| Sterile | Non-sterile | Non-sterile | Non-sterile | Same |
| Single Use | Yes | Yes | Yes | Same |
| Types, Class (ISO 6872:2015) | Type II, Class 3 | Type II, Class 3 | Type II, Class 2 | Similar (New device same as Predicate A, different from Predicate B) |
| Freedom from Extraneous materials | Free from extraneous materials | Free from extraneous materials | Not Reported | Same |
| Flexural Strength | $\geq300MPa$ | $\geq300MPa$ | $\geq100MPa$ | Same (As Predicate A, superior to Predicate B) |
| Linear thermal Expansion coefficient | $(9.8±0.5) x 10^{-6}/K$ | $(10.5±0.5) x 10^{-6}/K$ | $(11±0.5) x 10^{-6}/K$ | Similar |
| Glass Transition Temperature | $495±20°C$ | Not Reported | $520±20°C$ | Similar |
| 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.