(21 days)
Rhodia Putty Dental Impression Materials are intended for use for first impression in the technique of double impression.
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.
The provided text describes a 510(k) premarket notification for a dental impression material, Rhodia Dental Putty Impression Material. However, it does not contain the specific details required to answer your questions regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment.
The document states that the device "has been tested according to the criteria established in the Guidance Document, 'Dental Impression Materials-Premarket Notification'". This implies that there are established performance standards and testing methodologies for dental impression materials that the device has met. However, the document does not elaborate on what those criteria are, what the reported performance was, or any of the specific details about the study.
Therefore, I cannot provide the requested table, sample sizes, expert details, or ground truth information from this document. The information focuses on regulatory approval and substantial equivalence to pre-amendment devices, rather than a detailed performance study report.
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OCT 1 0 2001
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: (805) 653-5638
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 (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 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 .
§ 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).