(53 days)
- Cementation of crowns, bridges, inlays and onlays made of conventional porcelain, ceramic, hybrid ceramics, composite resin or metal
- Cementation of metal cores, resin cores, metal posts or glass-fiber posts
CLEARFIL SA CEMENT is a dual-cure (light-and/or self-adhesive resin cement for conventional porcclain, ceramic, hybrid ceramics (e.g. ESTENIA C&B), composite resin and metal restorations. It is classified into dental cement (21 CFR section 872.3275, Product code: EMA ) according to 21 CFR § 872 since it is composed of various materials other than zinc oxide-eugenol. According to the applicable FDA recognized consensus standard, ISO 4049: 2000 "Dentistry - Polymer-based filling, restorative and luting materials", this device is classified into the following: Class 3: materials that are cured by the application of external energy and also have a self-curing mechanism present
Here's the analysis of the provided text regarding the acceptance criteria and study for the device:
Device: CLEARFIL SA CEMENT (Dental adhesive resin cement)
510(k) Number: K081583
This submission focuses on demonstrating substantial equivalence to predicate devices, rather than an independent clinical study to establish acceptance criteria for novel performance claims. Therefore, the "acceptance criteria" discussed here are primarily compliance with an existing standard and comparative performance to predicates.
Acceptance Criteria and Reported Device Performance
| Criteria | Reported Device Performance |
|---|---|
| 1. Compliance with ISO 4049: 2000 "Dentistry - Polymer-based filling, restorative and luting materials" (specifically for Class 3 materials: dual-cure) | Verified: The device has been "verified to comply with the requirements of the applicable FDA recognized consensus standard, ISO 4049: 2000." It is classified as Class 3 under this standard. |
| 2. Chemical Ingredient Equivalence/Safety | Substantially Equivalent: "All the chemical ingredients of CLEARFIL SA CEMENT, the subject device, have been used in the predicate devices, PANAVIA F2.0 and CLEARFIL ESTHETIC CEMENT & DC BOND. It indicates that the safety of the applicant device is substantially equivalent to that of the predicate devices." (References tables in "Section 7: Substantial Equivalence Discussion") |
| 3. Effectiveness/Performance Equivalence to Predicate (MAXCEM) based on ISO 4049: 2000 | Effective as well as the predicate: "As to comparison with the predicate device, MAXCEM, according to ISO 4049; 2000, it was proved that both the subject one and the predicate one complied with ISO 4049: 2000 and the subject one should be effective as well as the predicate one." This implies comparative testing against MAXCEM, although specific numerical performance results are not provided in this summary, only the conclusion of compliance and equivalence. |
| 4. Intended Uses Equivalence | Equivalent: "It is intended to be used for the indications listed in the left hand column of the table of "Section 5: Executive Summary, Table 5" that are equivalent to the predicate devices, PANAVIA F2.0 and CLEARFIL ESTHETIC CEMENT & DC BOND." (Specific indications are listed in the "Indications for Use" section of the 510(k) – e.g., cementation of crowns, bridges, inlays, onlays, metal cores, resin cores, metal posts, glass-fiber posts.) |
| 5. Biocompatibility Equivalence | Substantially Equivalent: "All the chemical ingredients of CLEARFIL SA CEMENT, the subject device, have been used in the predicate devices... From those tables [on chemical ingredients], it can be said that the safety of the subject device is substantially equivalent to the predicate devices." |
Study Information:
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Sample size used for the test set and the data provenance:
- The document does not explicitly state the sample size used for specific tests within ISO 4049: 2000 or for the comparative effectiveness study against MAXCEM.
- Data provenance is not specified (e.g., country of origin, retrospective/prospective). Dental material testing standards like ISO 4049 typically involve in vitro laboratory tests.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as the studies described appear to be in vitro laboratory tests (compliance with ISO 4049) rather than studies requiring expert interpretation of clinical data or images.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable for in vitro laboratory tests.
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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, an MRMC comparative effectiveness study was not done. This device is a dental cement, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This isn't an algorithm; it's a dental material.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For compliance with ISO 4049, the "ground truth" would be established by the measurement protocols and physical properties defined within the ISO standard itself, measured by laboratory equipment. For example, mechanical strength, film thickness, water sorption, solubility, etc.
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The sample size for the training set:
- Not applicable. This is a physical product, not an AI model requiring a training set.
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How the ground truth for the training set was established:
- Not applicable. (Same as above).
Summary of the "Study":
The "study" referenced in the 510(k) summary is primarily focused on demonstrating compliance with the international standard ISO 4049: 2000 ("Dentistry - Polymer-based filling, restorative and luting materials") for the physical and chemical properties of the dental cement. Additionally, a comparative evaluation against a predicate device (MAXCEM) was performed to show that both met the ISO standard, leading to the conclusion that the subject device is "effective as well as the predicate one." The primary evidence for substantial equivalence lies in the chemical composition being identical to or derived from predicate devices, and the material's physical properties meeting an established performance standard. No clinical trials or human-reader studies are mentioned or evidently required for this type of device and submission.
§ 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.