(92 days)
Not Found
Not Found
No
The description focuses on measuring electrical properties (voltage, current, power) and does not mention any AI/ML algorithms for analysis or interpretation.
No.
The device is described as a caries detection device that aids dental professionals in identifying potential carious lesions by measuring voltage and other electrical properties. It does not treat or cure any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "aids the dental professional in detecting potential caries" and "aids in determing potentially active caries," which are diagnostic functions.
No
The device description explicitly states it has "two probes" and "meter's electronics," indicating physical hardware components beyond just software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The Oral Potential Meter (OPM) is used directly on the patient's teeth within the oral cavity. It measures electrical properties in vivo, not in a laboratory setting on a sample.
- The device description and intended use clearly indicate direct interaction with the patient's teeth. It uses probes to take measurements within the oral cavity.
Therefore, the OPM falls under the category of a medical device used for direct patient assessment, not an IVD.
N/A
Intended Use / Indications for Use
Caries detection Device
The Oral Potential Meter aids the dental professional in detecting potential caries. Meaurements above 10 millivolts, 1 microamp and 0.01 microwatts x seconds indicates a need for the dental professional to look at potentially carious leasions by also using other means, such as direct exploration, radiographs, etc. The OPM aids in determing potentially active caries and can not detect mineralized caries that have no potenial energy. Remineralized teeth are no longer considered carious.
Product codes
LFC
Device Description
The OPM is a device that measures and displays voltage and conducts through caries related to metallic restorations in the oral cavity. The dentist may be able to, on visual exam, detect caries at the margins or with x-ray under a restoration with these readings. It also provides a power measurement (energy or joules) integrated over a measured period of time and displays it. The meter has two probes that are used to make the measurements. One is a reference probe, Red, with push-button switch to turn on the meter and initiate the measurements. The other is used as the primary input, Black to the meter's electronics
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental professional
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.1740 Caries detection device.
(a)
Identification. The caries detection device is a device intended to show the existence of decay in a patient's tooth by use of electrical current.(b)
Classification. Class II.
0
Image /page/0/Picture/2 description: The image shows a black and white graphic. On the left side of the image, there is a stylized design that appears to be a logo or emblem. The design consists of curved lines and shapes, creating an abstract and flowing form. The word "DEZAR" is written vertically along the side of the design. To the right of the design, there is a horizontal line.
SEP 1 6 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Douglas L. Cook, DDS, SC Pertec of Wisconsin, Incorporated 10971 Clinic Road Suring, Wisconsin 54174 USA
Re : K982105 Trade Name: Oral Potential Meter (OPM) " Regulatory Class: II Product Code: LFC Dated: June 24, 1998 Received: July 31, 1998
Dear Dr. Cook:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰੈ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
1
Page 2 - Dr. Cook
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fdaj.gov/cdrh/dsmamairr:html".
Sincerely yours
Timothy A. Ulatowski
Director
Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(K) Number (if known): K982105
Device Name: Oral Potential Meter
Indications For Use: Caries detection Device
The Oral Potential Meter aids the dental professional in detecting potential caries. Meaurements above 10 millivolts, 1 microamp and 0.01 microwatts x seconds indicates a need for the dental professional to look at potentially carious leasions by also using other means, such as direct exploration, radiographs, etc. The OPM aids in determing potentially active caries and can not detect mineralized caries that have no potenial energy. Remineralized teeth are no longer considered carious.
The OPM is a device that measures and displays voltage and conducts through caries related to metallic restorations in the oral cavity. The dentist may be able to, on visual exam, detect caries at the margins or with x-ray under a restoration with these readings. It also provides a power measurement (energy or joules) integrated over a measured period of time and displays it. The meter has two probes that are used to make the measurements. One is a reference probe, Red, with push-button switch to turn on the meter and initiate the measurements. The other is used as the primary input, Black to the meter's electronics
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of device Evaluation (ODE)
Susan Runner
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number