(37 days)
For Metal Supported restorations with conventional cementation
For Metal Supported restorations using SR Adoro Thermo Guard
- Veneering of metal supported restorations using SR Adoro Thermon CRA Adoro
- Veneering of metal supported restorations using ON Pincho Station Thermo Guard
- Veneering of combined dentures (e.g. telescope veneers) using SFA Adoro Thermo Guard
- Veneering of combined dentares (e.g. Ichoope veng SR Adoro Thermo Guardina
Veneering of partially removable implant superstructures using SPAArco - Veneering of partially removable implant superstructures using SF Adoro Themo Guard Guard
- Fabrication of Iong-term temporaries using SR Adoro Thermo Guard
- Fabrication of forig-tenn tomporanes with SR Adoro Opaquer Pink.
For Metal-Free restorations
With Adhesive Cementation: - Inlays/Onlays/Veneers
- Anterior crowns without Vectris framework
- Anterior orowns with Vectrist framework
- Antenor and posterior Crowns was will Wectris framework
- 3-unit antenor and positis framework
With Conventional Cementation :
Conventional Cementation . - long-term temporaries with Vectris framework for a maximum duration of wear of 12 months.
- For removable prosthetics
For removable prostnetics - Surface characterization of Ivoclar Vivadent denture teeth with SR Adoro Stains. Surfaces must subsequently be covered with SR Adolo layering material.
- Surface characterization with SR Adoro layering material.
- Shade and shape modifications of Ivociar Vivadent denture teeth with SR Adoro layering material in conjuction with SR Composiv.
Not Found
This document is a 510(k) clearance letter from the FDA for a dental device called "SR Adoro®". It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and lists its intended uses and contraindications.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study from the provided text.
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.