AROMA FINE (NORMAL AND FAST SET)

• K Number: K994077
• Device Name: AROMA FINE (NORMAL AND FAST SET)
• Manufacturer: GC AMERICA, INC.
• Date Cleared: 2000-01-27 ( 56 days)
• Product Code: ELW
• Regulation Number: 872.3660
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Aroma Fine is a dust free alginate impression material used for taking impressions to obtain a detailed reproduction of the oral anotomy.

Device Description

Aroma Fine is a dust free alginate impression material

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a dental impression material called "Aroma Fine." It states that the device is substantially equivalent to legally marketed predicate devices. However, the letter does not contain any information regarding acceptance criteria, study details, device performance, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the provided text. The document is a regulatory approval, not a scientific study report.

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).