(31 days)
- Luting metal crowns, bridges, inlay, and onlays including porcelain-fused-to-metal and composite-to-metal varieties;
- Luting resin crowns, bridges, inlays, onlays and veneers;
- Luting metal or non-metal/fiber posts;
- Luting orthodontic appliances;
- Luting porcelain inlays, onlays, crowns, and veneers (includes alumina and zirconia).
BisCem is a dual-cured self etching and self adhosive resin cement. It is a self-adhesive cement since it bonds to composite, metal, silanated porcelain and tooth structure without applying any adhesive. No etching step is required to bond to dentin or enamel. With its dual syringe system. BisCem can be self cured by simply mixing paste B or cured by light after mixing paste A and paste B. Using a mixing tip, the cement could be dispensed to the working area directly. It is intended for use as a luting cement. Due to the unique chemistry of BisCem, refrigeration is necessary when not in use. Allow refrigerated BisCem to reach room temperature before use.
The provided text describes a 510(k) premarket notification for a dental cement called BisCem. The purpose of this submission is to demonstrate that a modified version of BisCem is substantially equivalent to a legally marketed predicate device (the original BisCem, K060701).
Here's an analysis based on your request, structured to address each point:
1. A table of acceptance criteria and the reported device performance
The provided summary does not explicitly state specific numerical acceptance criteria for performance parameters such as bond strength, film thickness, or radiopacity. Instead, it relies on a qualitative statement of "significant performance characteristics" and "side by side comparisons."
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| Intended Use | Luting cement |
| Chemical Composition | Dual-cured (self/light) dental glass filled, resin cement |
| Mechanical/Physical Properties | Low viscosity, dispensable composite |
| Safety and Efficacy | "proven the safety and efficacy of this product" |
Note: The submission highlights that the modified formula is a "dual-cured radiopague dental cement" and that "Its physical properties are similar to the predicate device." This implies that the properties (e.g., bond strength, film thickness, radiopacity, handling characteristics) were compared to the predicate, and met the unstated acceptance criteria of being "similar" or "substantially equivalent." However, no specific numerical values or ranges are provided in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide any details regarding:
- The sample size used for any testing.
- The data provenance (e.g., country of origin, retrospective or prospective nature of the data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of device submission. This is a dental material, and the "ground truth" for its performance would typically come from laboratory tests (e.g., bond strength testing, film thickness measurements, solubility, radiopacity assessment) and potentially in-vitro or in-vivo animal studies, not from human expert consensus on a test set in the way an AI diagnostic device would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the reasons stated in point 3.
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
This information is not applicable. This is a dental material, not an AI diagnostic device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a dental material, not an algorithm, so "standalone performance" in this context refers to the material's properties as measured in laboratory or clinical studies, without human intervention in the measurement process itself (beyond performing the test according to protocol). The summary does not provide details on these specific tests or their methodology.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For this type of device (dental cement), the "ground truth" would be established through objective physical and chemical property measurements performed in a laboratory, and potentially through clinical observations (though no clinical studies are mentioned in this summary). Examples of such measurements include:
- Bond strength (e.g., to dentin, enamel, metals, ceramics)
- Film thickness
- Radiopacity
- Solubility
- Setting time
- Flexural strength
- Compressive strength
The summary implies that these types of tests were conducted to demonstrate "physical properties are similar to the predicate device" and that "side by side comparisons clearly demonstrate that the applicant device is substantially equivalent."
8. The sample size for the training set
This information is not applicable. This is a dental material, not an AI model requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated in point 8.
Summary of the Study:
The study referenced is a 510(k) premarket notification (K082449) submitted by Bisco, Inc. for a modified dental luting cement named BisCem. The core of such a submission is to demonstrate substantial equivalence to a previously cleared predicate device (in this case, the original BisCem, K060701, cleared in 2006).
The "study" or testing performed involved a side-by-side comparison of the modified BisCem with the predicate device. The goal was to show that:
- The modified device has the same intended use.
- Its chemical composition, while slightly changed (from "resin modified glass ionomer" to "resin cement"), results in "dual-cured (self/light) dental glass filled, resin cement" which is considered functionally equivalent to the predicate.
- Its mechanical/physical properties are similar (low viscosity, dispensable composite).
- Overall, the safety and efficacy of the modified product were proven through this comparison, leading to the conclusion of substantial equivalence.
The specific test methods, number of samples, or detailed results are not present in this Special 510(k) Summary. The FDA's clearance letter confirms their review of the submission and their determination of substantial equivalence, allowing the device to be marketed.
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.