MEMOREG

• K Number: K971155
• Device Name: MEMOREG
• Manufacturer: HERAEUS KULZER, INC.
• Date Cleared: 1997-05-22 ( 55 days)
• Product Code: ELW
• Regulation Number: 872.3660
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

MEMOREG is indicated for bite registration in all standard situations with a stable occlusion.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a dental bite registration material called "Memoreg." It is not a study report and therefore does not contain information about acceptance criteria, device performance, sample sizes, ground truth establishment, or any details related to clinical studies.

The letter simply states that the FDA has reviewed the manufacturer's submission and determined that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

Therefore, I cannot provide the requested information based on the given text. The input does not contain a study that proves the device meets acceptance criteria.

Regulation Number and Section

§ 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).