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K Number
K042860
Device Name
CORRECT DENTAL IMPRESSION MATERIAL
Manufacturer
HANDAE CHEMICAL CO., LTD.
Date Cleared
2004-12-03

(49 days)

Product Code
ELW
Regulation Number
872.3660
Type
Traditional
Panel
DE
Reference & Predicate Devices
K042600
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Correct is used for all crown and bridge and implant impression techniques.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a dental impression material named "Correct Dental Impression Material." It does not contain any information about acceptance criteria, device performance, study details, ground truth, or sample sizes.

Therefore, I cannot fulfill your request using the provided input. The document is solely a regulatory clearance for a medical device and does not describe any specific studies or performance metrics.

§ 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).