(49 days)
TO PRODUCE LIGHT RANGE BETWEEN 400 & SOCIE CURE COMPOSITES CURED DENTAL RESTORATIVE MATERIAL SUCH AS LIGHT CURE COMPOSITES, PIT AND FISSURE SEALANTS, BONDING AGENTS, ADESION AND ARRESPANCE PIT AND FISSORE OFADINATE, ESTIGRATION OF FUCTION AND APPEARANCE OF THE TEETH OF PATIENT.
Not Found
I am sorry, but based on the provided document, I cannot answer the request as most of the information required to address the prompt is missing. The document is a 510(k) clearance letter for a dental light cure unit (O-Lite 75 Light Cure Unit), not a study report or a technical specifications document.
Here's a breakdown of why the information is missing:
- Acceptance Criteria and Performance Table: The letter states the device is "substantially equivalent" to pre-amendment devices, but it does not specify any performance acceptance criteria or report actual device performance metrics. This is typical for a 510(k) clearance, which focuses on equivalence rather than detailed performance studies against specific criteria.
- Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth Type, Training Set Size, Training Set Ground Truth: All these points relate to specific studies and their methodologies (e.g., clinical trials, bench testing with quantified results, reader studies). The 510(k) letter does not contain any such study details. It merely confirms regulatory clearance based on substantial equivalence.
Therefore, I cannot extract the requested information from this document.
§ 872.6070 Ultraviolet activator for polymerization.
(a)
Identification. An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.(b)
Classification. Class II.