(21 days)
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Not Found
No
The description focuses on the material properties and chemical reaction of a dental impression material, with no mention of AI or ML.
No
The device is a dental impression material used for diagnostic purposes (to create an impression of teeth) and not for treating or curing a disease or condition.
No
Explanation: The device is an impression material used to create molds of teeth, not to diagnose a medical condition.
No
The device description clearly states it is a two-part vinyl polysiloxane paste, which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to create dental impressions for use in a double impression technique. This is a physical process for capturing the shape of teeth and oral structures, not for testing samples taken from the body to diagnose or monitor a medical condition.
- Device Description: The device is a material used to create a physical mold. It does not involve analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as analyzing blood, urine, tissue, or other bodily fluids, or providing diagnostic information.
IVDs are used to perform tests in vitro (outside the body) on specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This dental impression material is used in vivo (within the body) to create a physical impression.
N/A
Intended Use / 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.
Product codes
ELW
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
Market Development Manager
Rhodia 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:
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:
1
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" .
: 上
2
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.
3
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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Image /page/4/Picture/0 description: The image shows a handwritten sequence of characters. The sequence starts with the letter 'K', followed by the digit '0', then '1', '3', '1', '4', and ends with '0'. The characters are written in a bold, black font, and they appear to be slightly slanted.
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__________________________________________________________________________________________________________________________________________________________