(243 days)
Permanent cementation of:
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- Porcelain fused to metal (PFM) to crowns and bridges
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- Prefabricated/cast posts
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- Metals to crowns, bridges, inlays & onlays, orthodontic appliances & posts
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- Ceramics (high strength)* to crowns & bridges, inlays & onlays
- *E.g. Zirconia, Lithium Disilicate,
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- Ceramics (low strength)* to inlays
- *E.g. Feldspathic porcelains, Glass ceramics
Riva Cem Automix™ is a radiopaque, fluoride releasing, resin modified glass ionomer luting cement.
Riva Cem Automix™ is intended for the cementation of crowns, bridges, inlays, posts (fibre-reinforced), and orthodontic appliances.
Riva Cem Automix™ consists of a base paste and a catalyst paste packaged in the automix delivery system for direct delivery in consistent mix ratios. Riva Cem Automix™ is available in a universal light-yellow shade in a double barrel syringe. The automix tip offers convenience over traditional hand mixed systems.
The product provides both self-cure and tack cure mechanisms which makes it versatile for the cementation of different restorative systems.
The provided text is a 510(k) premarket notification for a dental cement called "Riva Cem Automix." It focuses on demonstrating substantial equivalence to predicate devices through bench testing and biocompatibility testing, rather than an AI-powered diagnostic device. Therefore, it does not contain the information requested regarding acceptance criteria and a study proving an AI device meets those criteria.
Specifically, the document lacks information on:
- Acceptance criteria for an AI device and reported device performance: The document details acceptance criteria and performance for a dental cement, focusing on physical and chemical properties like working time, setting time, film thickness, flexural strength, radio-opacity, shear bond strength, and fluoride release. These are not acceptance criteria for an AI device.
- Sample size for a test set and data provenance: No AI test set is mentioned. The "performance data" section refers to in-vitro bench tests for a physical product.
- Number of experts and their qualifications for ground truth: Not applicable as it's not an AI device study requiring human expert labeling of data.
- Adjudication method for the test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted as it's not an AI device study.
- Standalone (algorithm-only) performance: Not applicable.
- Type of ground truth used: For the dental cement, the ground truth is established by standardized laboratory testing methods (e.g., ISO standards) measuring physical and chemical properties, not expert consensus or pathology on images.
- Sample size for the training set: Not applicable as no AI training set is mentioned.
- How ground truth for the training set was established: Not applicable.
In summary, the provided document describes the regulatory approval of a dental cement, not an AI medical 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.