(13 days)
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Not Found
No
The summary describes a traditional dental impression material and contains no mention of AI, ML, image processing, or performance studies typically associated with AI/ML devices.
No
The device is used to reproduce the structure of teeth and gums (for impressions), not to treat a disease or condition.
No
The device is described as an impression material used to reproduce the structure of teeth and gums, which is a manufacturing or physical reproduction process, not a diagnostic one.
No
The device description explicitly states "Multiple (POLY SILOXANE IMPRESSION MATERIAL)", which is a physical material used for taking impressions, indicating it is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The intended use and device description clearly state that this device is an "impression material" used to reproduce the structure of teeth and gums. This is a physical process of creating a mold, not a diagnostic test performed on a biological sample.
- Lack of Diagnostic Information: The description does not mention any analysis of biological samples, detection of biomarkers, or any other activity related to diagnosing a disease or condition.
Therefore, this device falls under the category of a dental impression material, which is a medical device but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Device intended to be placed intraorally or on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums.
Product codes
ELW
Device Description
Multiple (POLY SILOXANE IMPRESSION MATERIAL)
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
intraorally, patient's teeth and gums
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.
Public Health Service
NOV - 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jeanette Smith Operations Manager Millennium Dental International, Incorporated 1980 Hyde Park Road London, Ontario, N6H5L9 CANADA
Re: K053018
Trade/Device Name: Multiple (POLY Siloxane Impression Material) Regulation Number: 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: October 18, 2005 Received: October 26, 2005
Dear Ms. Smith:
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.
1
Page 2 - Ms. Smith
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. 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 vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
IUM DENTAL INTERNATIONAL, INC. ihmission: tiple-POLY SILOXANE IMPRESSION MATERIAL
ﻨﻬﻤ
| Indications for Use | |
|---|---|
| Applicant: | MILLENNIUM DENTAL INTERNATIONAL. INC. |
| 510(k) Number (if known): | K053018 |
| Device Name: | Multiple (POLY SILOXANE IMPRESSION |
| MATERIAL) | |
| Indications for Use: | Device intended to be placed intraorally or on a preformed |
| impression tray and used to reproduce the structure of a | |
| patient's teeth and gums. |
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use__ ×
OR (Per 21 CFR 801.109) Over-the-Counter Use__________
(Optional Format 1-2-96)
RSBetz005 for Dr Susan Lunner
nesthesion Infection Control. De
510(k) Number: K053018
1120 Federal Road • Brookfield, CT 06804