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K Number
K102739
Device Name
HYDROCOLOR 5
Manufacturer
CASCADES DEVICE CONSULTING ASSOCIATES
Date Cleared
2010-12-08

(77 days)

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

HYDROCOLOR 5 is a conventional alginate dental impression material intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth. It is also intended to provide models for study and for the production of restorative prosthetic devices, such as dental inlays and dentures.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance for the HYDROCOLOR 5 impression material. The text is a 510(k) clearance letter from the FDA, stating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory requirements and indications for use but does not include details on specific performance criteria or a study to demonstrate them.

§ 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).