(180 days)
Extraoral, permanent cementation of ceramic structures made of lithium disilicate glass ceramic (LS2) or zirconium oxide on titanium/titanium alloy or zirconium oxide bases.
Multilink® Hybrid Abutment is a self-curing luting composite for the extraoral, permanent cementation of ceramic structures made of lithium disilicate glass-ceramic (LS2) or zirconium oxide on titanium alloy or zirconium oxide bases (e.g. abutment or adhesive basis) in the fabrication of hybrid abutments or hybrid abutment crowns.
This is a 510(k) summary for a dental cement, not an AI/ML powered device. Therefore, many of the requested criteria regarding AI device studies are not applicable. I will address the applicable criteria based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Measured Performance) | Reported Device Performance (Multilink Hybrid Abutment Cement) | Predicate Device Performance (Multilink Implant - K090704) | Conclusion on Equivalence |
|---|---|---|---|
| Water Absorption (ISO 4049:2000) | Tested and results demonstrate substantial equivalence to predicate. | Not explicitly stated, but assumed to meet ISO 4049:2000. | Substantially Equivalent |
| Water Solubility (ISO 4049:2000) | Tested and results demonstrate substantial equivalence to predicate. | Not explicitly stated, but assumed to meet ISO 4049:2000. | Substantially Equivalent |
| Radiopacity (ISO 4049:2000) | Tested and results demonstrate substantial equivalence to predicate. | Not explicitly stated, but assumed to meet ISO 4049:2000. | Substantially Equivalent |
| Flexural Strength (ISO 4049:2000) | Tested and results demonstrate substantial equivalence to predicate. | Not explicitly stated, but assumed to meet ISO 4049:2000. | Substantially Equivalent |
| Modulus of Elasticity (ISO 4049:2000) | Tested and results demonstrate substantial equivalence to predicate. | Not explicitly stated, but assumed to meet ISO 4049:2000. | Substantially Equivalent |
| Compressive Strength (ISO 4049:2000) | Tested and results demonstrate substantial equivalence to predicate. | Not explicitly stated, but assumed to meet ISO 4049:2000. | Substantially Equivalent |
| Shear Bond Strength (ISO 4049:2000) | Tested and results demonstrate substantial equivalence to predicate. | Not explicitly stated, but assumed to meet ISO 4049:2000. | Substantially Equivalent |
| Biocompatibility (ISO 10993) | Testing and evaluation carried out according to ISO 10993. | Not explicitly stated, but assumed to meet ISO 10993. | Substantially Equivalent |
| Intended Use | Extraoral, permanent cementation of ceramic structures made of lithium disilicate glass ceramic (LS2) or zirconium oxide on titanium alloy or zirconium oxide bases. | Intraoral permanent cementation of restorations (implied from product name and comparison). | Differentiated by intraoral/extraoral use, but overall deemed substantially equivalent in context of cement properties. |
| Chemical Composition | Modified from the predicate. | Not explicitly stated, but implied to be different from the subject device. | Substantially Equivalent (despite modification, performance is equivalent) |
2. Sample size used for the test set and the data provenance
- Sample size: Not specified.
- Data provenance: Not specified, but likely from in-house laboratory testing based on the standards cited (ISO 4049:2000, ISO 10993). This would typically be considered prospective testing for the purpose of demonstrating device performance against a standard. The country of origin is not explicitly stated beyond "Ivoclar Vivadent, Inc. 175 Pineview Drive, Amherst, NY 14228".
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a material, not a diagnostic or AI device that requires expert ground truth for its performance evaluation in the context of the reported tests. Its performance is measured against physical and chemical standards.
4. Adjudication method for the test set
Not applicable. The tests are objective measurements of physical and chemical properties based on ISO standards.
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 not an AI/ML powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML powered device.
7. The type of ground truth used
For the performance tests (Water Absorption, Solubility, Radiopacity, Flexural Strength, Modulus of Elasticity, Compressive Strength, Shear Bond Strength), the "ground truth" or reference is the standards set forth by ISO 4049:2000. The biocompatibility "ground truth" is defined by ISO 10993. The device's performance is compared against these established material performance criteria and against the performance of its predicate device to claim substantial equivalence.
8. The sample size for the training set
Not applicable. This is not an AI/ML powered device. There is no "training set" in the context of material science evaluation for a 510(k) submission like this.
9. How the ground truth for the training set was established
Not applicable. As this is not an AI/ML powered device, there is no training set or associated ground truth establishment process in the AI sense.
§ 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.