Company: RGNT
Filing Date: 2025-10-24
Form Type: F-1/A
Source: 0001213900-25-101900
Chunk: 134

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-10-24
Form: F-1/A
Chunk 134
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 premarket notification requirement, manufacturers of most Class II devices are required to submit to
the FDA a premarket notification under Section 510(k) of the FDCA requesting permission to commercially distribute the device. The
FDA’s permission to commercially distribute a device subject to a 510(k) premarket notification is generally known as 510(k) clearance.
Devices deemed by the FDA to pose the greatest risks, such as life sustaining, life supporting or some implantable devices, or devices
that have a new intended use, or use advanced technology that is not substantially equivalent to that of a legally marketed device, are
placed in Class III, requiring approval of a PMA. Some pre-amendment devices are unclassified, but are subject to FDA’s premarket
notification and clearance process in order to be commercially distributed. We are in the process of pursuing approval of one of our
product candidates under a PMA.

510(k) Clearance Marketing Pathway

To obtain 510(k) clearance,
an applicant must submit to the FDA a premarket notification submission demonstrating that the proposed device is “substantially
equivalent” to a legally marketed predicate device. A predicate device is a legally marketed device that is not subject to premarket
approval, i.e., a device that was legally marketed before May 28, 1976 (pre-amendments device) and for which a PMA is not required,
a device that has been reclassified from Class III to Class II or I, or a device that was found substantially equivalent through
the 510(k) process. The FDA’s 510(k) clearance process usually takes from three to twelve months, but may take longer. The FDA
may require additional information, including clinical data, to make a determination regarding substantial equivalence. In addition,
FDA collects user fees for certain medical device submissions and annual fees for medical device establishments.

If the FDA agrees that the
device is substantially equivalent to a predicate device currently on the market, it will grant 510(k) clearance to commercially market
the device. If the FDA determines that the device is “not substantially equivalent” to a previously cleared device, the device
is automatically designated as a Class III device. The device sponsor must then fulfill more rigorous PMA requirements, or can request
a risk-based classification determination for the device in accordance with the “de novo” process, which is a route
to market for novel medical devices that are low to moderate risk and are not substantially equivalent to a predicate device.

After a device receives