Rhodia hydrophilic dental impression materials are intended for use with PUTTY set for second impression (impression of correction) in the technique of double impression.

Device Description

Rhodia hydrophilic dental impression material is intended for use for making intra-oral impressions. The device is a two-part vinyl polysiloxane paste with an addition-cure reaction. The base and catalyst pastes are extruded from dual-barrel cartridges through a mixing tip onto the surfaces of the teeth or onto a tray. The material quickly cures into a rigid impression. The hydrophilic property of the dental impression material helps to capture and reproduce perfect detail even in a moist environment.

AI/ML Overview

This document is a 510(k) summary for the Rhodia Hydrophilic Dental Impression Material. It does not contain the detailed study information generally required to describe acceptance criteria and device performance in the way you're requesting for a medical device that claims diagnostic or prognostic capabilities based on specific performance metrics like accuracy, sensitivity, or specificity.

Dental impression materials are typically evaluated against physical and chemical properties and their ability to accurately replicate oral structures. The provided text indicates the device has been tested according to the criteria established in the Guidance Document, "Dental Impression Materials-Premarket Notification". However, it does not list specific acceptance criteria or report device performance data in terms of those criteria.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details on sample sizes, ground truth establishment, expert involvement, or comparative effectiveness studies related to diagnostic accuracy, as this information is not present in the provided 510(k) summary.

The 510(k) process for this type of device primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device based on its intended use, technological characteristics, and safety and effectiveness, often through adherence to recognized standards for materials.

Based on the provided text, the following information can be extracted:

Device Name: Rhodia Hydrophilic Dental Impression Material
Intended Use: For making intra-oral impressions, specifically for "PUTTY set for second impression (impression of correction) in the technique of double impression."
Device Type: Two-part vinyl polysiloxane paste with an addition-cure reaction.

The following information cannot be extracted from the provided text, as it's not relevant to this type of device's 510(k) submission or is simply not present:

A table of acceptance criteria and reported device performance (in terms of specific quantitative metrics like accuracy, sensitivity, etc., which are not typically defined for impression materials in a 510k summary).
Sample sizes used for a "test set" in the context of diagnostic accuracy.
Data provenance.
Number of experts used to establish ground truth.
Qualifications of experts.
Adjudication method.
Multi-reader multi-case (MRMC) comparative effectiveness study information.
Standalone (algorithm only) performance.
Type of ground truth used (e.g., pathology, outcomes data).
Sample size for the training set.
How ground truth for the training set was established.

Summary of what can be gleaned about the study/testing:

The submission states: "Rhodia dental impression material is substantially equivalent to preamendment vinyl polysiloxane dental impression materials and has been tested according to the criteria established in the Guidance Document, "Dental Impression Materials-Premarket Notification"."

This indicates that testing was performed to demonstrate compliance with a recognized guidance document for dental impression materials. This testing would typically involve evaluating physical and chemical properties relevant to impression materials (e.g., tear strength, dimensional stability, working time, setting time, contact angle for hydrophilicity), rather than diagnostic accuracy. The specific results of these tests and the acceptance criteria are not detailed in this 510(k) summary.

Summary

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OCT 1 0 2001

Rhodia Hydrophilic Dental Impression Material

510(k) Notification

This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92

The assigned 510(k) number is: KO13140

Contact Person:	Alain MorinMarket Development ManagerRhodia Inc.320 W. Stanley Ave.Ventura, CA 93001
	Telephone: (805) 653-5638 extension 206
Date Prepared:	September 2001

Device Name and Classification:

Proprietary Name:	Rhodia Hydrophilic Dental Impression Material
Common Name:	Dental Impression Material
Product Code:	ELW

Manufacturer:

Rhodia Chem Italia S.p.A. Via Winckelmann, 2 20146 Milano ltaly

Device Description:

Substantial Equivalence Claim:

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Rhodia dental impression material is substantially equivalent to preamendment vinyl polysiloxane dental impression materials and has been tested according to the criteria established in the Guidance Document, "Dental Impression Materials-Premarket Notification" .

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three parallel lines forming its wings, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 0 2001

Mr. Alain Morin Market Development Manager Rhodia Incorproated 320 West Stanley Avenue Ventura, California 93001

Re: K013140

Trade/Device Name: Rhodia Hydrophilic Dental Impression Material Regulation Number: 872.3660 Regulation Name: Dental Impression Material Regulatory Class: II Product Code: ELW Dated: September 17, 2001 Received: September 19, 2001

Dear Mr. Morin:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of Amendments, or to do roometic Act (Act) that do not require approval of a premarket the reach application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Mr.), I may be afound in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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Page 2 - Mr. Morin

You must comply with all the Act's requirements, including, but not limited to: registration r ou into comply with and 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirences as bet forms in are quadiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 110(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the and cathlenand in 1 - 2 at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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RHODIA HYDROPHILIC DENTAL IMPRESSION MATERIAL

510(k) Notification

Indications for Use Statement

510(k) Number:

KOL3140

Device Name:

Rhodia Hydrophilic Dental Impression Material

Indications for Use:

Rhodia hydrophilic dental impression materials are intended for use with PUTTY set for second impression (impression of correction) in the technique of double impression.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANTOHER PAGE AS NEEDED)

Susan Rave

(Division Sign-Off) Division of Dental, Infection Control, and General Hospita 510(k) Number

Prescription Use

[Image of a check mark]

Over the Counter Use__________________________________________________________________________________________________________________________________________________________

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).