(202 days)
Filling material as a treatment for dental caries
The subject devices are a mixture (alloy) of silver and several other metals, used by dentists to make fillings for tooth cavities. Amalgam alloys have been the most commonly used direct restorative filling material for over a 100 years.
The provided text describes a 510(k) summary for several dental amalgam devices, asserting their substantial equivalence to a predicate device. This submission focuses on comparing the physical and chemical properties of the devices to establish this equivalence, rather than on the performance of an AI-powered diagnostic device.
Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set sample size, ground truth for training set) are not applicable to this document as it does not describe a study involving an AI-powered diagnostic device that requires such metrics for validation.
Here's the information that can be extracted relevant to acceptance criteria and performance:
1. A table of acceptance criteria and the reported device performance:
| Product Characteristic | Acceptance Criteria (from ISO 24234) | Subject Devices Performance (Reported as complying) | Predicate Device Performance | Difference & Remarks |
|---|---|---|---|---|
| Chemical Composition | ||||
| Silver (Ag) (CAS 7440-22-4) | ≥ 40% | a) 44.5%; b) 70% | 56% | Compositions meet the requirements of ISO 24234. |
| Tin (Sn) (CAS 7440-31-5) | ≤ 32% | a) 30%; b) 18% | 27.9% | Compositions meet the requirements of ISO 24234. |
| Copper (Cu) (CAS 7440-50-8) | ≤ 30% | a) 25.5%; b) 12% | 15.4% | Compositions meet the requirements of ISO 24234. |
| Zinc (Zn) | ≤ 2% | Not explicitly stated, but implied to meet criteria | 0.2% | Compositions meet the requirements of ISO 24234. |
| Alloy-mercury Ratio | Not explicitly stated as a single criterion, but values provided | 1:1 (Mercury 50%) | Varies between 1/0.86 and 1/0.96 (46.2% to 49.5% by weight mercury) | Compositions meet the requirements of ISO 24234. |
| Physical Properties | ||||
| Particle shape & size | Not specified by a standard | Admix - spherical and lathe cut 15 μm - 35 μm | Admix - spherical and lathe cut 15 μm - 35 μm | This parameter is not specified by a technical standard; depends on product characteristics. Amalgams made from lathe-cut powders or admixed powders tend to resist condensation better. |
| Compressive strength @ 1hr | > 100 MPa | 171 MPa | 260 MPa | Data received is similar and products tested per ISO 24234. All results are within specifications and provide good performance of restoration. |
| Compressive strength @ 24hr | > 350 MPa | 443 MPa | 500 MPa | Data received is similar and products tested per ISO 24234. All results are within specifications and provide good performance of restoration. |
| Working times (minutes) - Condense | Not explicitly a criterion | 2.5 - 5 | 2.5 - 5 | No significant difference. |
| Working times (minutes) - Carving | Not explicitly a criterion | 4.5 - 7 | 5.5 - 7 | No significant difference. |
| Corrosion products (μg/cm²) | Not explicitly a criterion | 2 | 2.5 | No significant difference. |
| Ions leached and mercury vapor released during corrosion (ng/cm² in 4 hrs) | Not explicitly a criterion |
§ 872.3070 Dental amalgam, mercury, and amalgam alloy.
(a)
Identification. Dental amalgam is a device that consists of a combination of elemental mercury, supplied as a liquid in bulk, sachet, or predosed capsule form, and amalgam alloy composed primarily of silver, tin, and copper, supplied as a powder in bulk, tablet, or predosed capsule form, for the direct filling of carious lesions or structural defects in teeth. This device also includes the individual component devices, mercury and amalgam alloy, when intended to be combined with each other to form dental amalgam.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy.”See § 872.1(e) for the availability of this guidance document.