(163 days)
[1] Cementation of crowns, bridges, inlays and onlays
[2] Cementation of prosthetic restorations on implant abutments and frames
[3] Cementation of adhesion bridges and splints
[4] Cementation of posts and cores
[5] Amalgam bonding
The subject device is a dual-cure (light- and/or self-cure), fluoride releasing, radiopaque self-adhesive resin cement for ceramic (porcelain, lithium disilicate, zirconia, etc.), composite resin, and metal restorations.
The provided document is a 510(k) premarket notification for a dental cement device, PANAVIA SA Cement Plus Handmix. It is not an AI/ML medical device, therefore, the requested information about acceptance criteria, study details for AI/ML performance, and human reader comparative effectiveness studies is not applicable.
This document describes the substantial equivalence of the new device to existing predicate devices based on:
- Intended Uses: The intended uses of the subject device are substantially equivalent to those of the predicate devices.
- Chemical Ingredients/Safety: While the subject device contains 5 new ingredients, biological safety tests (referring to ISO 10993 series and ISO 7405) concluded substantial equivalence to the predicate device in biological safety.
- Technological Characteristics/Effectiveness and Performance: Physical and mechanical properties were evaluated according to ISO 4049:2009. Tensile bond strength to bovine dentin and shear bond strength to implant abutment were evaluated according to ISO/TS 11405:2003. Released fluorine ion levels were also compared.
Table of Acceptance Criteria and Reported Device Performance (based on provided information):
| Performance Metric (ISO Standard) | Acceptance Criteria (Compliance) | Reported Device Performance (PANAVIA SA Cement Plus Handmix) |
|---|---|---|
| Film thickness, luting materials (ISO 4049: 5.2.2) | COMPLIES | COMPLIES |
| Working time, Class 1 and Class 3 luting materials (ISO 4049: 5.2.4) | COMPLIES | COMPLIES |
| Setting time, Class 3 materials (ISO 4049: 5.2.6) | COMPLIES | COMPLIES |
| Flexural strength (ISO 4049: 5.2.9) | COMPLIES | COMPLIES |
| Water sorption (ISO 4049: 5.2.10) | COMPLIES | COMPLIES |
| Solubility (ISO 4049: 5.2.10) | COMPLIES | COMPLIES |
| Color stability after irradiation and water sorption (ISO 4049: 5.4) | COMPLIES | COMPLIES |
| Radio-opacity (ISO 4049: 5.5) | COMPLIES | COMPLIES |
| Tensile bond strength to bovine dentin (ISO/TS 11405: 2003) | In-house standard COMPLIES | COMPLIES (no statistically significant difference from predicate) |
| Shear bond strength to implant abutment (ISO/TS 11405: 2003) | In-house standard COMPLIES | COMPLIES (no statistically significant difference from predicate) |
| Released fluorine ion | Substantially equivalent to predicate | Substantially equivalent to predicate |
Summary of Device Evaluation for AI/ML-specific questions:
The provided document does not pertain to an AI/ML medical device. Therefore, the following information is not present and not applicable:
- Sample size for the test set and data provenance: Not applicable.
- Number of experts used to establish ground truth for the test set and their qualifications: Not applicable.
- Adjudication method for the test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance study: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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.