(61 days)
Sultan Genie Ultra Hydrophilic Impression Material is intended for use as a dental impression material. The material is dispensed from an automatic mixing cartridge system and placed into dental impression trays (metal or plastic) and is used to accurately reproduce intra-oral structures (teeth & gums) to provide models for study and/or fabrication of prosthetic devices.
Not Found
This is a 510(k) clearance letter from the FDA for Sultan Genie™ Ultra Hydrophilic Impression Material, classifying it as substantially equivalent to a predicate device. This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner typically expected for an AI/ML medical device.
The provided text pertains to a traditional dental impression material, not an AI/ML-based device. Therefore, the details requested (such as sample size for test/training sets, expert qualifications, HRMC studies, standalone performance, etc.) are not applicable to this submission.
The "acceptance criteria" and "study" mentioned in the context of this document would refer to the standards for dental impression materials (e.g., rheology, dimensional stability, tear strength, hydrophilic properties, biocompatibility) and the non-clinical bench testing or potentially limited clinical evaluations demonstrating that the Sultan Genie™ material performs comparably to the identified predicate devices for its intended use.
Based on the provided text, I cannot furnish the requested information because it is not an AI/ML device submission.
However, I can extract the relevant information from this document:
- Device Name: Sultan Genie™ Ultra Hydrophilic Impression Material
- Intended Use: As a dental impression material, dispensed from an automatic mixing cartridge system, placed into dental impression trays (metal or plastic) to accurately reproduce intra-oral structures (teeth & gums) to provide models for study and/or fabrication of prosthetic devices.
- 510(k) Number: K030414
- Regulatory Class: II
- Product Codes: ELW
To reiterate, the questions posed in your prompt (e.g., sample size for test set, expert qualifications, MRMC study, standalone performance) are designed for AI/ML device submissions, which this document is not.
§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).