(220 days)
The Merz Dental GmbH Denture Base Resins with Prosthetic Color System (Promolux, Promolux Hi, Weropress and PremEco PCS) are indicated for:
- Relining a denture surface that contacts tissue ●
- Repairing a fractured denture, or
- Forming a new denture base
Merz Dental Denture Base Resins with Prosthetic Color System are composed of the following products:
• Promolux: A heat processed PMMA denture base resin
• Promolux Hi: A heat-processed PMMA denture base resin formulated for greater strength
· Weropress: A two part cold curing PMMA denture base resin
: PremEco PCS: A two part cold curing PMMA denture base resin with individual tints for aesthetic coloration of gingival portion of a denture base
These products are intended for the preparation of denture bases. They are composed of PMMA and cured by standard heat or cold setting methods. The Prosthetic Color System is a three part system composed of the following: (1) PMMA polymer with various tints in a powder form, (2) MMA liquid for mixing with the powder, and (3) a cold-casting resin (PMMA and MMA) for final preparation of the denture base. The hot and cold curing denture materials contain standard dental colorants and catalyst systems. One of the hot cured dental base materials, Promolux Hi, is formulated to increase impact resistance.
This document is a 510(k) Summary for Merz Dental GmbH Denture Base Resins with Prosthetic Color System. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a study with performance metrics in the way a medical imaging AI would. Therefore, many of the requested categories (e.g., sample size for test/training, number of experts, adjudication method, MRMC studies, standalone performance) are not applicable to this type of submission.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are that the device materials meet the requirements of two international ISO standards for denture base polymers. The reported device performance is that the materials met these standards.
| Acceptance Criteria (ISO Standard) | Reported Device Performance |
|---|---|
| ISO 1567:2000 "Dentistry -Base polymers - Part 1: Denture base polymers" (for cold curing -- Type II: Class 1) | The materials "met the physical and residual methyl methacrylate monomer requirements" of this standard. |
| ISO 20795-1 "Dentistry - Base polymers - Part 1: Denture base polymers" (for hot curing-Type II, Class 2) | The materials "met the physical and residual methyl methacrylate monomer requirements" of this standard. |
| ISO 10993-5 (In Vitro Cytotoxicity) | The materials "were tested and found to comply with in vitro cytotoxicity." |
| ISO 10993-10.2 (Guinea Pig Sensitization) | The materials "were tested and found to comply with guinea pig sensitization." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. Performance testing for material properties typically involves laboratory-controlled testing of material samples, not patient data. The provenance for such tests would usually be the testing laboratory, which is not specified beyond being performed by the manufacturer.
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)
This information is not applicable/provided. Ground truth, in the context of this 510(k), refers to material property measurements against established international standards (ISO). This typically involves laboratory technicians and machinery, not clinical experts establishing a ground truth from patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. Adjudication methods are relevant for clinical assessments, especially in cases where human readers are establishing ground truth from medical images. For material property testing, the measurements are objective.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-assisted image interpretation, which is not the subject of this 510(k) submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This submission details physical material properties of denture resins, not the performance of an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the material performance testing was based on references to international standards (ISO 1567:2000, ISO 20795-1, ISO 10993-5, ISO 10993-10.2). The materials were tested to ensure they met the specified requirements in these standards for physical and biological properties.
8. The sample size for the training set
This information is not applicable/provided. There is no "training set" in the context of material property testing for denture resins. The submission focuses on demonstrating that the final product meets specified standards.
9. How the ground truth for the training set was established
This information is not applicable/provided. As there is no training set, there is no ground truth established for one.
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.