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K Number
K192992
Device Name
Suglue 3
Manufacturer
3M Deutschland GMBH
Date Cleared
2019-11-05

(11 days)

Product Code
EMA
Regulation Number
872.3275
Type
Traditional
Panel
DE
Reference & Predicate Devices
K110508,K100756
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Use of Suglue 3 in Adhesive Mode with ADH19
·Final cementation of all-ceramic or metal Maryland bridges and 3-unit inlay/onlay bridges
·Final cementation of all-ceramic or composite veneers and occlusal veneers (tabletops)

Use of Suglue 3 in Adhesive Mode with ADH19 or in Self-Adhesive Mode

·Final cementation of all-ceramic, composite, or metal inlays and onlays, crowns, and bridges

·Final cementation of posts made of ceramic, glass fiber-reinforced composite or metal, and screws

·Final cementation of all-ceramic, composite, or metal restorations on implant abutments

Device Description

Suglue 3 is a dual-curing universal cement that is used for both adhesive and self-adhesive cementation of indirect restorations and posts, whereas RelyX Unicem 2 Automix is a selfadhesive cement and RelyX Ultimate is an adhesive cement. New redox initiator system provides improved bond strength to tooth structure, especially dentin. Changed characteristics allow easier excess removal. Increased radioopacity facilitates clinicians to see the Suglue 3 in radiographs as well as tooth like fluorescence for an esthetic appearance, especially in the anterior region. Suglue 3 is used in combination with ADH19 (dental adhesive, product of 3M Deutschland GmbH) for adhesive cementation. ADH19 adhesive is self-etching. Optionally, the adhesive strength can be enhanced further through additional etching of the tooth structure with Scotchbond Universal Etchant (product of 3M Deutschland GmbH). Standard cases as well as post cementations can be solved securely and efficiently when Suglue 3 is used in selfadhesive mode.

AI/ML Overview

The provided FDA 510(k) document details the clearance of a dental cement, Suglue 3. It primarily focuses on demonstrating substantial equivalence to predicate devices through comparisons of indications for use, composition, technology, and various physical and mechanical properties.

Crucially, this document does not describe acceptance criteria, a study proving device performance against such criteria in the context of an AI/ML device, or any of the specific AI/ML related questions posed (e.g., sample size for test set, ground truth experts, MRMC studies, standalone performance, training set details).

The document is for a medical device (dental cement) and does not involve AI or machine learning. Therefore, the requested information regarding AI/ML device performance and study design elements cannot be extracted from this text.

The information from the document related to general device performance studies is as follows:

  1. A table of acceptance criteria and the reported device performance:

    • The document does not provide a table of explicit acceptance criteria with specific thresholds for each performance metric. It rather states that "The results of Suglue 3 are comparable to RelyX Unicem 2 Automix, and RelyX Ultimate."
    • Reported performance (in comparison to predicate devices):
      • Excess removal forces (comparable)
      • Pull-out bond strength to endodontic post (comparable)
      • Shear bond strength to tooth structure (dentin and enamel), glass ceramic (feldspathic and lithium disilicate ceramics), zirconia, metals (gold, remanium, and titanium), and composites (comparable)
      • Film thickness (comparable)
      • Working time (comparable)
      • Flexural strength (comparable)
      • Water sorption (comparable)
      • Solubility (comparable)
      • Shade (comparable)
      • Color stability (comparable)
      • Radioopacity (comparable)
      • Compressive strength (comparable)

  2. Sample size used for the test set and the data provenance:

    • Not applicable as this is a physical dental cement, not an AI/ML device using a test set of data. The document does not specify sample sizes for the in vitro tests conducted.
    • Data provenance is not mentioned beyond the tests being "in vitro."

  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    • Not applicable. The "ground truth" here would refer to the measured physical and mechanical properties of the cement, established through standardized laboratory testing, not by expert interpretation of data.

  4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

    • Not applicable. This concept applies to human expert review of clinical data, not to physical property testing of a dental cement.

  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:

    • Not applicable. This is for an AI/ML device, which Suglue 3 is not.

  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

    • Not applicable. This is for an AI/ML device, which Suglue 3 is not.

  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

    • For the physical and mechanical properties of the dental cement, the "ground truth" is established through direct measurement and testing methods, some of which are based on ISO standards (e.g., ISO 4049:2009, ISO 9917-1:2008).

  8. The sample size for the training set:

    • Not applicable. There is no AI/ML model to train for this device.

  9. How the ground truth for the training set was established:

    • Not applicable. There is no AI/ML model to train for this device.

§ 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.