(79 days)
The Vitique System is intended for use in permanent luting of definitive restorations of all kinds (metal, ceramic, composite), including veneers, crowns and bridges, onlays, telescopic crowns, attachments, pins and posts, orthodontic appliances, luting of ornaments, splinting etc. as well as a add-on for resin based materials. The Try-in pastes may also be used as a general water soluble separating agent (e.g. isolating material for use with prefabricated crowns, retraction cords etc.) or as an oxyguard gel.
The Vitique System consists of: Vitique Cement a highly aesthetic luting cement in various shades; Try-In Pastes that precisely match the corresponding cement shade to approximate the final result: Silanating agent for use in preparing ceramic surfaces for bonding; and Contax Bonding System a bonding system (etching gel, bonding system) for final bonding to tooth structure.
The provided documents are a 510(k) summary and FDA clearance letter for a dental luting material called the Vitique System. This type of submission is for a medical device (dental cement) and does not involve AI or algorithms that would have performance acceptance criteria in the way typically associated with AI/ML diagnostic devices.
Therefore, most of the requested information regarding acceptance criteria, study details, ground truth, and AI-specific performance metrics (like MRMC studies) is not applicable to this submission.
Here's a breakdown of what can be extracted and what is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the submission is an "Abbreviated 510(k)" and demonstrates conformity with "FDA's guidance document entitled Dental Cements - Premarket Notification, August 1998" and "ISO 4049 - Dentistry - Polymer-based filling, restorative and luting materials."
This means the acceptance criteria are based on the standards outlined in ISO 4049 and the general safety and effectiveness requirements for dental cements as per FDA guidance. The submission claims conformity, but specific quantitative acceptance criteria and detailed reported performance values are not provided in the summary. For example, ISO 4049 would specify requirements for properties like:
| Acceptance Criteria (Examples based on ISO 4049 for luting materials)** | Reported Device Performance (Not explicitly detailed in summary) |
|---|---|
| Flexural Strength: > 50 MPa (e.g.) | Conforms to ISO 4049 |
| Water Sorption: |
§ 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.