(148 days)
SmarTemp® X I is a self-curing composite for the fabrication of temporary crowns and bridges, inlays and veneers. SmarTemp® X1 is intended for the fabrication of: temporary crowns, bridges, inlays, long-term temporaries, and temporary veneers.
SmarTemp® X1 is a self-curing, resin-based composite, suitable for the fabrication of temporary crowns, bridges, inlays, onlays, and veneers. It is a bis-acryl resin-based material comprising a 10:1 ratio of base to catalyst components, which when expressed by the user from dual-chamber syringes or cartridges mix through standard snap-in accessory mixing tips. SmarTemp® X1 self-cures in approximately 6 minutes at mouth temperature.
SmarTemp® X1 is packaged in any standard, opaque, dual-chamber syringe or cartridge suitable for containing a 10:1 ratio of base and catalyst components, respectively. The syringe or cartridge is accompanied by standard snap-in automix tips.
The provided text describes the regulatory clearance of a dental material, SmarTemp X1, as substantially equivalent to a predicate device, Luxatemp Ultra/Star. It does not contain information about a clinical study or acceptance criteria related to an AI/ML powered medical device.
However, based on the provided document, I can extract information related to the acceptance criteria and testing for the SmarTemp X1 dental material, which serves as a substitute for the requested AI/ML device information.
Here's the breakdown of the acceptance criteria and the study (bench performance testing) for SmarTemp® X1:
SmarTemp® X1 Acceptance Criteria and Bench Performance Study
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for SmarTemp® X1 appear to be based on demonstrating equivalence or meeting certain thresholds compared to the predicate device, Luxatemp® Ultra/Star, for critical physical properties.
| Property | Acceptance Criteria (Predicate Device K101710) | Reported Device Performance (SmarTemp® X1) |
|---|---|---|
| Compressive Strength | >300 MPa | >300 MPa |
| Flexural Strength | >100 MPa | >100 MPa |
| Shrinkage |
§ 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.