(102 days)
ConTec Light is used to set resinous dental adhesive material by transmission of visible light.
Not Found
This request cannot be fulfilled. The document provided is an FDA 510(k) clearance letter for a dental light curing device called "ConTec Light". It confirms substantial equivalence to a predicate device and allows the manufacturer to market it.
However, the document does NOT contain any information regarding:
- Acceptance criteria table or reported device performance metrics (e.g., accuracy, sensitivity, specificity).
- Any details about a study that proves the device meets specific performance criteria.
- Sample sizes, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, types of ground truth, or training set details.
The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive performance studies with detailed statistical analyses as might be found in a PMA (Premarket Approval) submission for a novel, high-risk device, or a publication describing a clinical trial for an AI-powered diagnostic.
Therefore, I cannot extract the requested information from the provided text.
§ 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.