(163 days)
Base it is a light-cured, radiopaque dental liner and base material that Contains calcium bydroxyl apatite in a urethane dimethacrylate oligomer. Base it is used to line cavity preparations before restoration.
Base it is light-cured Cavity Liner. It is radiopaque cavity liner and base material specially formulated for use with adhesives, composites and conventional restorative materials. It has urethane dimethacrylate base and is similar in chemistry to dental composites.
The provided 510(k) summary for SPIDENT Co., Ltd.'s "Base it" device describes its performance testing in comparison to a predicate device, LIME-LITE (K953079). This submission serves as a notice of intent to market, asserting substantial equivalence to the predicate, rather than a detailed study for a novel device. Therefore, much of the requested information (like specific sample sizes for test sets, training data, number of experts, adjudication methods, or MRMC studies) is not typically included in such a submission for a substantially equivalent device.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission implicitly uses the performance characteristics of the predicate device, LIME-LITE, as the acceptance criteria. The claim is that "Base it" is equivalent in these aspects.
| Acceptance Criteria (based on predicate device) | Reported Device Performance ("Base it") |
|---|---|
| Flexural strength | "Testing performed including Flexural strength... which demonstrated that the Base it is equivalent to the predicates in specifications and performance characteristics." |
| "The Base it has the similar mechanical properties as the predicate device: Flexural Strength." | |
| Depth of cure | "Testing performed including ...Depth of cure... which demonstrated that the Base it is equivalent to the predicates in specifications and performance characteristics." |
| "The Base it has the similar mechanical properties as the predicate device: ...Depth of cure" | |
| Compressive strength | "Testing performed including ...Compressive strength... which demonstrated that the Base it is equivalent to the predicates in specifications and performance characteristics." |
| "The Base it has the similar mechanical properties as the predicate device: ...Compressive Strength" | |
| Radio-opacity | "Testing performed including Radio-opacity... which demonstrated that the Base it is equivalent to the predicates in specifications and performance characteristics." |
| Water sorption | "Testing performed including ...Water sorption... which demonstrated that the Base it is equivalent to the predicates in specifications and performance characteristics." |
| Solubility | "Testing performed including ...Solubility... which demonstrated that the Base it is equivalent to the predicates in specifications and performance characteristics." |
| "The Base it has the similar mechanical properties as the predicate device: ...and Solubility" | |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation/Intracutaneous reactivity, Subacute toxicity, Genotoxicity) | "Biocompatibility testing confirmed that the device meets the applicable requirements of the FDA Blue Book Memorandum #95-1... and is biocompatible." |
| Results: |
- Cytotoxicity: Pass
- Sensitization: Pass
- Irritation or Intracutaneous reactivity: Pass
- Subacute toxicity: Pass
- Genotoxocity: Pass |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. Standard bench testing typically uses a specific number of samples per test (e.g., 5, 10, or more) to achieve statistical significance for material properties, but this detail is not provided in a 510(k) summary.
- Data Provenance: The tests were "performed" by SPIDENT Co., Ltd. The country of origin for the data collection is implied to be Korea, where the company is located. The nature of the data is prospective bench testing, conducted specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a bench study concerning physical and chemical properties of a dental material, not an AI or diagnostic device requiring expert interpretation of results. The "ground truth" for these tests comes from established testing methodologies and material science standards.
4. Adjudication method for the test set
Not applicable. As a bench study, results are quantitative and measured against established material science standards, not subjective interpretations requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
No. This is not an MRMC study. It is a bench study comparing a new device's material properties to a predicate device, not evaluating human reader performance with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a dental material, not an algorithm.
7. The type of ground truth used
The ground truth used for performance validation is based on established material science standards and specifications for dental restorative materials. These standards dictate how properties like Flexural Strength, Depth of Cure, etc., are measured and what acceptable ranges or equivalence criteria are. The biocompatibility tests are based on the ISO 10993 series of standards.
8. The sample size for the training set
Not applicable. This is a new material, not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 872.3250 Calcium hydroxide cavity liner.
(a)
Identification. A calcium hydroxide cavity liner is a device material intended to be applied to the interior of a prepared cavity before insertion of restorative material, such as amalgam, to protect the pulp of a tooth.(b)
Classification. Class II.