(156 days)
[1] Cementation of crowns, bridges, inlays and onlays
[2] Cementation of veneers
[3] Cementation of adhesion bridges and splints
[4] Cementation of prosthetic restorations on implant abutments and frames
[5] Cementation of posts and cores
[6] Amalgam bonding
The subject device is an adhesive resin cement system. It consists of the cement paste (Paste), Try-in Paste, Tooth Primer, CLEARFIL CERAMIC PRIMER PLUS and K-ETCHANT Syringe. The Paste is a dual-cure (light- and/or self-cure), fluoride-releasing, radiopaque resin cement for ceramics (lithium disilicate, zirconia, etc.), hybrid ceramics, composite resins, and metal restorations. It is supplied in an automix delivery system which mixes equal amounts of two components. It is available in the following 5 shades; Universal (A2), Clear, Brown (A4), White, and Opaque. The Opaque shade should be self-cured for final curing due to its strong opacity. The Try-in Paste is a shade matching material which has approximate color and transparency as the hardened mixture of Paste. The Tooth Primer is a self-etching primer to tooth structures that accelerates the polymerization of the Paste.
The provided text is a 510(k) Summary for the dental cement "PANAVIA V5". It describes the device, its intended use, and comparative studies against predicate devices to establish substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Section | Requirement | PANAVIA V5 (Subject device) Performance | Acceptance Criteria Met? |
|---|---|---|---|
| 5.2.2 Film thickness, luting materials | 60 seconds | COMPLIES (for all shades) | Yes |
| 5.2.5 Setting time, Class 1 materials or 5.2.6 Setting time, Class 3 materials |
§ 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.