(101 days)
- Final cementing of all-ceramic, composite, or metal inlays, onlays, crowns and bridges; 2-3-unit Maryland bridges and 3-unit inlay/onlay bridges (excluded for patients with bruxism or periodontitis)
- Final cementing of posts and screws .
- Final cementation of all-ceramic, or composite veneers ●
- Final cementation of all-ceramic, composite, or metal restorations on implant . abutments
Suglue-10, manufactured by 3M ESPE, is a dual-curing resin cement supplied in an automix syringe. It is intended to be used for the adhesive cementation of indirect restorations and will be available in various shades. Suglue-10 is intended to be used in combination with an adhesive, e.g. Adhesive EXL 759 (by 3M ESPE). The Adhesive EXL 759 can be used either as a "Total Etch" or "Self-Etch" procedure. The additional etching of the tooth structure increases the adhesive strength of the adhesive even further. Suglue-10 contains bi-functional (meth)acrylate. The proportion of inorganic fillers is about 43% by volume; the grain size (D 90%) is about 13 µm. The mixing ratio, based on volume, is 1 part base paste : 1 part catalyst.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Suglue-10 device:
The provided document is a 510(k) Summary of Safety and Effectiveness, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific clinical efficacy of the device as a standalone product through extensive clinical trials. Therefore, much of the information typically found in a study demonstrating a device meets acceptance criteria (especially for AI/ML devices) will not be present.
Based on the provided information, the "acceptance criteria" are the performance limits defined by the ISO standards and the "device performance" refers to the results obtained for Suglue-10 in comparison to these limits and its predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Method | Acceptance Criteria (Limit) | Suglue-10 Results | Predicate (Malta) Results |
|---|---|---|---|---|
| Film thickness | ISO 4049 | 60 sec | pass | pass |
| Setting time | ISO 4049 | 1.0 mm | 2.3 mm | 1.8 mm |
| Flexural Strength | ||||
| dark cured | ISO 4049 | > 50 MPa | 77 ± 5 MPa | 84 ± 12 MPa |
| light cured | ISO 4049 | > 50 MPa | 111 ± 7 MPa | 111 ± 16 MPa |
| Compressive Strength | ||||
| dark cured | ISO 9917 | na [MPa] | 278 ± 9 MPa | 263 ± 9 MPa |
| light cured | ISO 9917 | na [MPa] | 286 ± 36 MPa | 256 ± 36 MPa |
| Surface Hardness | ||||
| dark cured | ISO 2039-1 | na [MPa] | 187 ± 12 MPa | 190 ± 20 MPa |
| light cured | ISO 2039-1 | na [MPa] | 217 ± 83 MPa | 212 ± 30 MPa |
Note: "na" for compressive strength and surface hardness limits indicates "not applicable" or that specific numerical limits were not defined in this summary, but rather the comparison was made to the predicate device.
2. Sample Size Used for the Test Set and Data Provenance
The document provides performance results but does not specify the sample sizes used for the various tests (e.g., how many samples were tested for film thickness, flexural strength, etc.).
There is also no explicit mention of data provenance in terms of country of origin or whether the data was retrospective or prospective. The manufacturer is 3M ESPE AG in Germany, implying the testing likely took place in Germany, but this isn't stated directly as "data provenance."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable and not provided in this document. The "tests" performed are objective, physical/mechanical property measurements based on ISO standards for dental cements, not subjective evaluations requiring expert interpretation or ground truth establishment in the context of clinical images or diagnostic decisions.
4. Adjudication Method for the Test Set
This is not applicable and not provided. The testing performed involves standardized physical and chemical measurements governed by ISO methods, not subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This is not applicable. Suglue-10 is a dental cement, not an AI/ML device or a diagnostic imaging tool that would involve human readers or AI assistance in interpretation. Therefore, an MRMC study and related effect sizes are irrelevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. Suglue-10 is a physical dental material, not an algorithm or software device.
7. The Type of Ground Truth Used
The "ground truth" for the performance data is based on standardized physical and chemical measurements conducted according to established International Organization for Standardization (ISO) methods (ISO 4049, ISO 9917, ISO 2039-1) for dental materials. These methods define how the properties are measured objectively, not through expert consensus, pathology, or outcomes data in a clinical sense.
8. The Sample Size for the Training Set
This is not applicable and not provided. As Suglue-10 is a physical product and not an AI/ML device, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
This is not applicable. As Suglue-10 is a physical product and not an AI/ML device, there is no "training set" or "ground truth for the training set."
Summary of the Study Proving Device Meets Acceptance Criteria:
The "study" presented here is a premarket notification (510(k)) submission for a dental cement. The purpose of this submission is to demonstrate substantial equivalence to existing legally marketed predicate devices, not to conduct a comprehensive clinical trial or establish de novo safety and effectiveness.
The study proves the device meets "acceptance criteria" by showing that its physical and chemical properties (film thickness, working time, setting time, radiopacity, flexural strength, compressive strength, surface hardness) are within acceptable limits defined by international ISO standards and are comparable to or better than a legally marketed predicate device (Malta).
The document states: "In summary, it can be concluded that Suglue-10 is as safe and effective as the predicate devices: Malta by 3M ESPE, Germany (K100756), Panavia F 2.0 by Kuraray Medical Inc., Japan (K032455), and Nexus 3 by Kerr Corporation, U.S.A. (K062519)." This conclusion is based on the comparative performance data, chemical composition analysis, and comparison of indications for use. Biocompatibility testing was also carried out, though the specific results are not detailed in this summary.
§ 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.