RHODIA HYDROPHILIC DENTAL IMPRESSION MATERIAL

K013140 · Rhodia, Inc. · ELW · Oct 10, 2001 · Dental

Device Facts

• Record ID: K013140
• Device Name: RHODIA HYDROPHILIC DENTAL 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 hydrophilic dental impression materials are intended for use with PUTTY set for second impression (impression of correction) in the technique of double impression.

Device Story

Rhodia Hydrophilic Dental Impression Material is a two-part vinyl polysiloxane paste; utilizes addition-cure reaction. Base and catalyst pastes are extruded from dual-barrel cartridges through a mixing tip onto teeth surfaces or a tray. Material cures into a rigid impression. Hydrophilic properties facilitate detail capture in moist intra-oral environments. Used by dental professionals in clinical settings to create accurate dental impressions for restorative or diagnostic purposes.

Clinical Evidence

bench testing only

Technological Characteristics

Two-part vinyl polysiloxane paste; addition-cure reaction; hydrophilic formulation; supplied in dual-barrel cartridges with mixing tips; rigid final set.

Indications for Use

Indicated for use in dental procedures requiring a second impression (impression of correction) using the double impression technique.

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

## 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 Morin<br>Market Development Manager<br>Rhodia Inc.<br>320 W. Stanley Ave.<br>Ventura, CA 93001 |
|-----------------|------------------------------------------------------------------------------------------------------|
| | Telephone: [phone] 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:

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.

# 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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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 [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 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]

or

Over the Counter Use__________________________________________________________________________________________________________________________________________________________