RHODIA DENTAL PUTTY IMPRESSION MATERIAL

K013129 · Rhodia, Inc. · ELW · Oct 10, 2001 · Dental

Device Facts

• Record ID: K013129
• Device Name: RHODIA DENTAL PUTTY IMPRESSION MATERIAL
• Applicant: Rhodia, Inc.
• Product Code: ELW · Dental
• Decision Date: Oct 10, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

Rhodia Putty Dental Impression Materials are intended for use for first impression in the technique of double impression.

Device Story

Rhodia Dental Putty is a two-part vinyl polysiloxane impression material; utilizes addition-cure reaction. Base and catalyst components are mixed manually by dental professionals prior to application. Used for first impressions in double impression techniques; compatible with metal or plastic perforated and non-perforated trays. Provides accurate dental impressions for clinical diagnostic or restorative procedures.

Clinical Evidence

Bench testing only; tested according to criteria established in the FDA Guidance Document 'Dental Impression Materials-Premarket Notification'.

Technological Characteristics

Two-part vinyl polysiloxane; addition-cure reaction chemistry. Form factor: putty. Manual mixing required.

Indications for Use

Indicated for use as a first impression material in double impression techniques for dental patients.

Regulatory Classification

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.

Special Controls

*Classification.* Class II (Special Controls).

Submission Summary (Full Text)

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OCT 1 0 2001

K013129

## Rhodia Dental Putty 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:

Contact Person: Alain Morin Rhodia Inc. 320 W. Stanley Ave. Ventura, CA 93001

Telephone: [phone]

Date Prepared: September 2001

## Device Name and Classification:

| Proprietary Name: | Rhodia Dental Putty 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:

Rhodia Putty is used for first impression in the technique of the double impression. It can be used with perforated and non-perforated trays constructed of metal or plastic.

The device is a two-part vinyl polysiloxane putty with an addition-cure reaction. The base and catalyst components are mixed together prior to creating an impression.

## Substantial Equivalence Claim:

Rhodia dental impression material is substantially equivalent to pre-

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amendment 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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OCT 1 0 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Alan Morin Market Development Manager Rhodia Incorporated 320 West Stanley Avenue Ventura, California 93001

Re: K013129

Trade/Device Name: Rhodia Dental Putty Impression Material Regulation Number: 872.3660 Regulation Name: Dental Impression Material Regulatory Class: II Product Code: ELW Dated: September 14, 2001 Received: September 19, 2001

Dear Mr. 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 the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions 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 your device can be found 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 and listing (21 CFR Part 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 applicable, the electronic product radiation 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 510(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 Office of Compliance at [phone] . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy Ulatowski 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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013129
CONFIDENTIAL

RHODIA DENTAL PUTTY IMPRESSION MATERIAL

510(k) Notification

Indications for Use Statement

510(k) Number:

Rhodia Dental Putty Impression Material. Device Name:

Indications for Use:

Rhodia Putty Dental Impression Materials are intended for use for first Rhoula I atty Dontal in the technique of double impression.

(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANTOHER PAGE AS NEEDED)

Swan Rasner

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