(105 days)
Halley resin is a light-cured resin indication of dentures bases in dental laboratories, including full and partial dentures as well as implant overdentures, and other dental appliances. Halley resin can be used as a try-in material for evaluation prior to fabrication of the final restoration of these prostheses require a computer-aided design and manufacturing (CAD/CAM) system using an additive printer.
Halley resin can be utilized as an aid in bonding denture teeth as well as repair using traditional techniques.
The proposed Halley resin is a methacrylate-based, light-cured resin available in multiple shades and is intended as an alternative to traditional heat cured and autopolymerization denture base resins. The Halley resin is intended to be utilized primarily for the fabrication of dental prostheses using an additive printer and CAD/CAM techniques. The proposed Halley resin can also be used for traditional repairs and as an aid in bonding denture base to denture teeth.
In addition, Halley resin may also be utilized as an aid in bonding the printed denture to teeth as well as for repair.
The document describes the acceptance criteria and study proving the device meets them for the "Halley resin."
1. Table of Acceptance Criteria and Reported Device Performance:
| Physical Property | Standard (ISO) Specification Limit (Type 4) | Standard (ISO) Specification Limit (Type 2) | Proposed Device Halley resin (Type 4) Reported Performance | Predicate Device NextDent™ Denture / E-Denture (K162572) (Type 4) Reported Performance* | Reference Device Pour Acrylic (K161330) (Type 2) Reported Performance** |
|---|---|---|---|---|---|
| Ultimate Flexural Strength (MPa) | 65 MPa min. | 60 MPa min. | Meets ISO 20795-1:2013 for Type 4 material | Meets ISO 20795-1:2013 for Type 4 material (>65 MPa) | Meets ISO 20795-1:2013 for Type 2 material |
| Flexural Modulus (MPa) | 2000 MPa min. | 1500 MPa min. | Meets ISO 20795-1:2013 for Type 4 material | Meets ISO 20795-1:2013 for Type 4 material (>2000 MPa) | Meets ISO 20795-1:2013 for Type 2 material |
| Water Sorption (µg/mm³) | 32 µg/mm³ max. | 32 µg/mm³ max. | Meets ISO 20795-1:2013 for Type 4 material | Meets ISO 20795-1:2013 for Type 4 material (≤ 32 µg/mm³) | Meets ISO 20795-1:2013 for Type 2 material |
| Water Solubility (µg/mm³) | 1.6 µg/mm³ max. | 8.0 µg/mm³ max. | Meets ISO 20795-1:2013 for Type 4 material | Exceeds ISO 20795-1:2013 for Type 4 material ( |
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.