(8 days)
This device is intended for use as a dental cement. RelyX™ Luting Plus Automix (Lexus-2) is indicated for Luting:
- Luting porcelain fused to metal crowns and bridges to tooth structure, amalgam, composite or glass ionomer core build ups;
- Luting metal inlays, onlays or crowns;
- Luting pre-fabricated and cast post cementation
- Luting orthodontic appliances
- Luting crowns made with all-alumina or all zirconia cores such as Procera® AllCeram
3M™ ESPE™ RelyX™ Luting Plus Automix (Lexus-2) is a radiopaque, fluoride-releasing, resinmodified glass ionomer luting cement. It is self-curing with an option for tack light curing of excess cement. RelyX Luting Plus Automix (Lexus-2) consists of a base (Paste A) and catalyst (Paste B) packaged in an automix (dual barrel) syringe. The dual barrel syringe dispenses paste A and Paste B. The cement is available in a white shade.
The provided text describes the acceptance criteria and a study demonstrating that the device, RelyX™ Luting Plus Automix, meets these criteria.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are established by comparing the performance of the new device (RelyX™ Luting Plus Automix, referred to as Lexus 2) against a legally marketed predicate device (3M™ ESPE™ RelyX™ Luting Plus Cement, K022476). The reported device performance is indicated by "pass" for all tested properties, signifying that Lexus 2 met or exceeded the design specifications, which are implicitly acceptable as they are compared to a predicate device.
| Properties | Method | Lexus 2 Design Specification | Lexus2 Ave and Predicate (K022476) Performance |
|---|---|---|---|
| Flexural strength (FS) (MPa) | ISO 9917-2 | ≥ 10 MPa | pass |
| Radio-opacity (mm of Al) | ISO 9917-2 | ≥1.0mm of Al | pass |
| Adhesion to dentin (MPa) | 3M ESPE internal | ≥2 MPa | pass |
| Adhesion to enamel (MPa) | 3M ESPE internal | ≥2 MPa | pass |
| Adhesion to Metal (MPa) | 3M ESPE internal | ≥2 MPa | pass |
| Adhesion to Lava™ (MPa) zirconia | 3M ESPE internal | ≥2 MPa | pass |
| Adhesion to composites | 3M ESPE internal | ≥2 MPa | pass |
| Adhesion to amalgam | 3M ESPE internal | ≥2MPa | pass |
| Adhesion to Titanium (MPa) | 3M ESPE internal | ≥2 MPa | pass |
| Adhesion to Lithium disilicate (MPa) | 3M ESPE internal | ≥2 MPa | pass |
| Fluoride release (µg F/g) at 90 days | 3M ESPE internal | ≥500 | pass |
| Film thickness (microns) | ISO 9917-2 | ≤ 25 | pass |
| Work time (s) | 3M ESPE internal | ≥ 90s | pass |
| Set time (s) | 3M ESPE internal |
§ 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.