(93 days)
everX Flow is a reinforcing dentin replacement material suitable for:
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- All direct composite restorations including large posterior cavities.
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- Deep cavities and endo-treated teeth.
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- Cavities with missing cusps or after amalgam removal and cavities where inlays would also be recommended.
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- Core build-up
everX Flow is a light cured, short-fiber-reinforced composite for dentin replacement for the restoration of posterior and anterior teeth. EverX Flow is filled in a syringe. The material is available in two shades, Bulk shade and Dentin shade.
The provided document pertains to a 510(k) premarket notification for a dental device named "everX Flow," a tooth shade resin material. This document focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through bench testing (performance testing) and biocompatibility assessment, rather than clinical performance testing involving human subjects or AI-assisted diagnostic studies.
Therefore, many of the requested details regarding acceptance criteria, study methodologies (like sample size for test sets, number of experts, adjudication, MRMC studies, standalone AI performance), and ground truth establishment for a diagnostic AI device are not applicable to this submission. This is a material science and dental product regulatory submission, not a medical AI/software as a medical device (SaMD) submission.
However, I can extract and present the acceptance criteria and performance data that are relevant to this type of device, which is primarily laboratory bench testing.
Acceptance Criteria and Reported Device Performance for everX Flow (Dental Resin Material)
This device, "everX Flow," is a dental restorative material, not an AI or diagnostic device. Therefore, the "acceptance criteria" refer to the physical, chemical, and biological properties of the material itself, as tested in a laboratory setting according to international standards (ISO 4049:2009 and ISO 10993-1:2009 for biocompatibility).
1. Table of Acceptance Criteria and Reported Device Performance
| Property | Acceptance Criteria (Requirements per ISO 4049:2009) | Reported Device Performance (Compliance) |
|---|---|---|
| Sensitivity to ambient light | Remain physically homogeneous | Conforms |
| Depth of cure (Opaque shade) | > 1.0 mm | Conforms (similar to predicate) |
| Depth of cure (Other shade) | > 1.5 mm | Conforms (similar to predicate) |
| Flexural strength | > 80 MPa | Conforms |
| Water sorption |
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.