Search Results
Found 1 results
510(k) Data Aggregation
(2 days)
- Bonding of indirect restorations made of composite, all-ceramic and metal.
- Bonding of prosthetic devices (crowns, inlays, onlays, bridges, and veneers) to cavities, abutment teeth, or implant abutments.
- Dental core bonding.
The subject device is a dual-cure resin cement for dental adhesion composed of two types of paste: the Catalyst Paste and the Base Paste. Each paste is filled separately in the independent double-barrel syringe and is mixed and dispensed through a dedicated mixing tip attached to the syringe nozzle. To match the color of the prepared tooth structure (dentin and enamel) and the prosthetic restoration, the Base Paste is available in four shades: Translucent, Yellow, White, and Opaque. The accessory tips include iCEM Universal Plus Mixing Tips and iCEM Universal Plus Endo Tips (consisting of Endo Mixing Tips and Extension Tips), which differ in tip diameter and are selected according to the clinical indication. All tips are single-use only. The mixed resin cement cures through both chemical and light polymerization. The subject device can adhere to tooth structure (dentin and enamel) using iCEM Universal Plus Cement, with or without the use of iCEM Universal Plus Primer, depending on the clinical indication:
• Self-Adhesive Mode: Using only iCEM Universal Plus Cement as a self-adhesive resin cement.
• Adhesive Mode: Using iCEM Universal Plus Cement in combination with the dedicated primer, iCEM Universal Plus Primer, as an adhesive resin cement.
When used in the adhesive mode, iCEM Universal Plus Primer contains a portion of the polymerization initiators involved in the chemical polymerization of the subject device. Upon contact with the subject device, these initiators are activated, initiating the polymerization of the monomers and resulting in curing. This combination enhances the bond strength to tooth structure (dentin and enamel) compared to the Self-Adhesive Mode.
N/A
Ask a specific question about this device
Page 1 of 1