(117 days)
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No
The summary does not mention AI, ML, or related concepts, nor does it describe features or performance metrics typically associated with AI/ML-powered devices.
No
The device is described as being used to "reproduce the structure of a patient's teeth and gums," which indicates a diagnostic or imaging purpose, not a therapeutic one. It does not mention treating or preventing a disease or condition.
No
The intended use describes the device as reproducing anatomical structure, not providing a diagnosis based on analysis of that structure.
No
The intended use describes a device that is placed intraorally or on a preformed impression tray to reproduce the structure of teeth and gums. This strongly suggests a physical device (like an intraoral scanner or impression material) rather than software alone. The lack of a device description further supports this interpretation, as a software-only device would typically describe the software's function and platform.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "reproduce the structure of a patient's teeth and gums" by being placed intraorally or on an impression tray. This is a physical process for creating a mold or replica of anatomical structures.
- Lack of Biological Sample Analysis: IVDs are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a physiological state, health, or disease. This device does not involve the analysis of any biological samples.
- Physical Reproduction: The function described is a physical reproduction of anatomical structures, not a diagnostic test based on biological markers.
Therefore, this device falls outside the scope of In Vitro Diagnostics. It appears to be a device used in dentistry for creating impressions or models.
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
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure, with three curved lines representing its body and wings. The logo is accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jeanette Smith Operations Manager Clinician's Choice Dental Products, Incorporated 1980 Hyde Park Road London, Ontario N6H 5L9 CANADA
AUG - 4 2008
Re: K081017
Trade/Device Names: Template and CounterFit Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: July 18, 2008 Received: July 22, 2008
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 your 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You mav 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Thhmuele Ferdinnd fox//
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
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CLINICIAN'S CHOICE TM Dental Products, Inc. 510(K) Submission: Multiple-Polydimethylsiloxanes Impression Material
Indications for Use
| 510(k) Number (if known): | K081017 |
|---|---|
| Device Name: | Template and CounterFit |
| 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. |
Prescription Use X (21 CFR Part 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR Part 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Intray
ﺍﻟﻤﻌﺎﺭﺿﺎﺕ ﺍﻟﻤﺪﻳﺮ ﺍﻟﻤﺪﻳﺮ ﺍﻟﻤﺪﻳﺮ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﻋﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣ Division of Antool, Dental Devices
510(k) Number: K081017
Section 2-3
1084 Federal Road . Brookfield, CT 06804