RHODIA BITE REGISTRATION MATERIAL

K013859 · Rhodia, Inc. · ELW · Jan 29, 2002 · Dental

Device Facts

• Record ID: K013859
• Device Name: RHODIA BITE REGISTRATION MATERIAL
• Applicant: Rhodia, Inc.
• Product Code: ELW · Dental
• Decision Date: Jan 29, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

Rhodia Bite Registration Material is intended for taking impressions of the biting surfaces of the teeth used to set gypsum casts in the correct occlusal relationship when the casts are mounted on an articulator.

Device Story

Rhodia Bite Registration Material is a two-part vinyl polysiloxane paste used in dental clinics. The material is dispensed via dual-barrel cartridges through a mixing tip onto a tray. It undergoes an addition-cure reaction to form a rigid impression of the teeth's biting surfaces. Dentists or dental professionals use the resulting impression to mount gypsum casts on an articulator, ensuring the correct occlusal relationship for restorative or diagnostic procedures. The device facilitates accurate dental model alignment, aiding in the fabrication of dental prosthetics or occlusal analysis.

Clinical Evidence

Bench testing only.

Technological Characteristics

Two-part vinyl polysiloxane paste; addition-cure reaction; dispensed via dual-barrel cartridges with mixing tip; rigid final set.

Indications for Use

Indicated for taking dental impressions of biting surfaces to set gypsum casts in correct occlusal relationship on an articulator.

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)

{0}------------------------------------------------

#### Rhodia Bite Registration Material

# 'JAN 2 9 2002

#### 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: | k013859 |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Alain Morin<br>Market Development Manager<br>Rhodia Inc.<br>320 W. Stanley Ave.<br>Ventura, CA 93001<br>Telephone: [phone] extension 206 |
| Date Prepared: | November 2001 |

#### Device Name and Classification:

| Proprietary Name: | Rhodia Bite Registration 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 Bite Registration Material is intended for taking impressions of the biting surfaces of the teeth used to set gypsum casts in the correct occlusal relationship when the casts are mounted on an articulator.

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 a tray. The material quickly cures into a rigid impression.

{1}------------------------------------------------

## Substantial Equivalence Claim:

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" ය

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the edge. In the center of the seal is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 9 2002

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

Re: K013859

Trade/Device Name: Rhodia Bite Registration Material Regulation Number: 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: November 20, 2001 Received: November 21, 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 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.

{3}------------------------------------------------

Page 2 - Mr. Morin

You must comply with all the Act's requirements, including, but not limited to: registration and You must comply with an the Act s requirences and 801);
listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice listing (21 CFR Part 807), labeling (2) CFR Parl (00) regulation (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 cF(2 of the Ar requirements as set forth in the quality Systems (QD) regarated (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)
I have and the may of a lot a first of a least of your device to alegal This letter will allow you to begin makemily of substantial equivalence of your device to a legally premarket notification. The FDA inding of substantial equivaliation of your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific advice for your devited diagnostic devices), please contact the Office of
additionally 21 CFR Part 809.10 for in the diagnostic devices, please contact additionally 21 CFR Part 809.10 for m vide users on the promotion and advertising of your Compliance at [phone]. Auditionally, for question Also, please note the regulation device, please contact the Office of Compination (21CFR Part 807.97). Other general
entitled, "Misbranding by reference to premarket not transal from the Division of Small entitled, "Misbranding by telefence to premarket from the Division of Small
information on your responsibilities under the Act may be in the sumber [phone] c information on your responsibilities macr assistance at its toll-free number [phone] or
Manufacturers, International and Consumer Assistance at its toll-free number (8 Manufacturers, International and Consumer Fibersailer in and consumers.
[phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
Lisa Allatrust

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

Enclosure

{4}------------------------------------------------

### RHODIA BITE REGISTRATION MATERIAL

510(k) Notification

Indications for Use Statement

510(k) Number:

K013859

Device Name:

Rhodia Bite Registration Material

Indications for Use:

Rhodia Bite Registration Material is intended for taking impressions of the biting surfaces of the teeth used to set gypsum casts in the correct occlusal relationship when the casts are mounted on an articulator.

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

Prescription Use

Over the Counter Use

Susan Rupp

or

ivision Sign-Off) Continuo of Dental, Infection Control, a Coneral Hospital (IO Number J