ORAL POTENTIAL METER (OPM)

K982105 · Pertec of Wisconsin, Inc. · LFC · Sep 16, 1998 · Dental

Device Facts

• Record ID: K982105
• Device Name: ORAL POTENTIAL METER (OPM)
• Applicant: Pertec of Wisconsin, Inc.
• Product Code: LFC · Dental
• Decision Date: Sep 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1740
• Device Class: Class 2

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

Device Story

Oral Potential Meter (OPM) measures electrical potential (voltage), current, and integrated power (energy/joules) associated with metallic restorations in the oral cavity. Device consists of two probes: a red reference probe with a push-button switch to initiate measurement and a black primary input probe. Used by dental professionals in a clinical setting to identify potentially active carious lesions. Measurements exceeding 10 millivolts, 1 microamp, and 0.01 microwatts-seconds signal the clinician to perform further diagnostic evaluation, such as direct exploration or radiographs. OPM does not detect mineralized caries lacking potential energy; remineralized teeth are not considered carious. Output provides quantitative data to assist clinical decision-making regarding the presence of active caries at restoration margins or beneath restorations.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Handheld meter with two-probe interface (red reference, black primary). Measures voltage, current, and integrated power (energy). Operates via electrical conductivity assessment related to metallic restorations. No specific materials, standards, or software architecture details provided.

Indications for Use

Indicated for dental professionals to aid in the detection of potentially active caries in patients with metallic restorations in the oral cavity. Not indicated for detecting mineralized caries lacking potential energy.

Regulatory Classification

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.

Submission Summary (Full Text)

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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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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## 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

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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