(98 days)
CAD/CAM veneering for anterior and posterior single crowns made of Lava Frame Zirconia, manufactured with Lava Design Software and the accordingly released Lava milling machine.
Elegant is classified as Porcelain powder for clinical use (21 C.F.R. § 872.6660). Elegant is used for production of glass ceramic veneers for 3M ESPE Lava™ Frame Zirconia frameworks.
Elegant consists of 4 glass ceramic blocks (E1 - E4), from which the veneer is milled. Each ceramic block is available in the two sizes S and M. The veneer is then fused to the Zirconia framework via color-coordinated fusion porcelain (D1 - D10). For smaller adjustments to the restoration, corrective porcelains (CR1 - CR4) can be used. For the tooth colors A4, B4, C3, C4, and D4, the basic shades ("Shade" A - D) must be used. The individual stains S1 (White), S2 (Lemon Yellow), S3 (Orange), S4 (Violet), S5 (Blue), S6 (Dark Brown), and glaze are used for individualization. For the mixing of the fusion porcelain powder and the corrective porcelain, modelling liquid is available; also, for stains and glaze, stain/glaze liquid is available.
For the production of an Elegant restoration, the Lava™ Frame Zirconia framework and the corresponding Elegant veneer are virtually designed on the screen with the Lava™ Design Software. The milling for both parts takes place in the accordingly released Lava™ milling machine with special milling cutters. Subsequently the Lava™ Frame Zirconia framework is shaped and then sintered in the Lava™ sintering furnace. All of the above-mentioned Lava products are manufactured by or for 3M ESPE.
This document is a 510(k) Summary for the device "Elegant," a porcelain powder for clinical use in dental restorations. It focuses on establishing substantial equivalence to predicate devices, rather than a traditional clinical study with acceptance criteria for device performance in terms of diagnostic accuracy or similar metrics.
Therefore, many of the requested elements pertaining to acceptance criteria and performance studies are not directly applicable or available in this type of submission, as it's not a clinical performance study evaluating outcomes like sensitivity or specificity. Instead, the "study" is a comparison to predicate devices, and the "acceptance criteria" are the demonstration of substantial equivalence.
Here's an interpretation based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied for 510(k) Equivalence) | Reported Device Performance (vs. Predicate) |
|---|---|
| Chemistry: Material composition similarities | Elegant consists of glass ceramic blocks (E1-E4), fusion porcelain (D1-D10), corrective porcelains (CR1-CR4), and individual stains (S1-S6) and glazes. These components are assumed to have similar chemical compositions to the predicate devices (Lava Ceram, IPS Empress Universal Shade/Stains, Glass Ceramics “Jolly,” Position Penta, Ketac Molar Quick). The submission explicitly states: "The comparison for chemistry... shows that Elegant is substantially equivalent to the predicate devices." |
| Performance Data: Physical/mechanical properties | While specific test results (e.g., flexural strength, wear resistance, color stability) are not detailed in this summary, the statement "The comparison for... performance data... shows that Elegant is substantially equivalent to the predicate devices" implies that such data was provided to the FDA and found to meet equivalence. The device's function involves milling and fusing to Zirconia frameworks, necessitating appropriate mechanical properties for dental restorations. |
| Indications for Use: Clinical application | Elegant is indicated for CAD/CAM veneering for anterior and posterior single crowns made of Lava Frame Zirconia, manufactured with Lava Design Software and the accordingly released Lava milling machine. This indication is deemed substantially equivalent to the indications of the predicate devices. The 510(k) decision letter (K091826) confirms acceptance of these indications for use. |
| Safety and Effectiveness: Overall assessment | The submission concludes: "In summary, it can be concluded that safety and effectiveness requirements for Elegant are completely met." This is the overarching "acceptance criterion" for a 510(k) submission, meaning the FDA agreed that the device is as safe and effective as the legally marketed predicate devices. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable in the context of this 510(k) summary. This document does not describe a clinical performance study with a test set of patient data. The "test" for a 510(k) is typically a comparison of device characteristics (chemistry, performance, indications) to existing devices. If any physical or mechanical properties were tested, the sample sizes would refer to experimental batches of materials, not a "test set" of patient data. The manufacturer is based in Germany.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This submission does not involve a diagnostic decision-making process requiring expert ground truth for a test set. The "ground truth" here is regulatory acceptance of equivalence based on the provided technical data and comparisons to predicate devices, reviewed by FDA officials.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There is no "test set" or adjudication of diagnostic findings described. The FDA's review process internally involves multiple reviewers, but this is a regulatory review, not a clinical adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a material for dental restorations, not an AI software or diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this 510(k) submission is the established characteristics and regulatory acceptance of the predicate devices. The new device's data (chemistry, performance, indications) is compared against these known, legally marketed predicates to demonstrate substantial equivalence.
8. The sample size for the training set
- Not applicable. This device is a material, not a machine learning model, so there is no training set.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, this question is not relevant.
§ 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.