MODIFICATION TO POTASSIUM NITRATE-POLYCARBOXYLATE DENTAL CEMENT

• K Number: K022025
• Device Name: MODIFICATION TO POTASSIUM NITRATE-POLYCARBOXYLATE DENTAL CEMENT
• Manufacturer: MILTON HODOSH, M.D.
• Date Cleared: 2002-08-15 ( 56 days)
• Product Code: EJK
• Regulation Number: 872.3250
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: K022025
• Predicate For: N/A

Intended Use

FOR LINING AND BASES UNDER AMALGAM AND/OR Composite RESTORATIONS AND FOR LUTING FULL CROWNS TO PREPARED TEETH.

Device Description

Not Found

AI/ML Overview

This document is a letter from the FDA to Dr. Milton Hodosh regarding the 510(k) premarket notification for the "Preserve Cavity Liner" (later referred to as not yet named, but a modification of "Potassium MIRRY's Lycon Epoxy LGTF DEVITAL CEMENT").

The letter approves the device as substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other specific details requested in your prompt.

The document is an approval letter for a medical device based on its substantial equivalence to previously approved devices, not a study report. Therefore, I cannot extract the requested information from this text.

Regulation Number and Section

§ 872.3250 Calcium hydroxide cavity liner.

(a)
Identification. A calcium hydroxide cavity liner is a device material intended to be applied to the interior of a prepared cavity before insertion of restorative material, such as amalgam, to protect the pulp of a tooth.(b)
Classification. Class II.