The following data is part of a premarket notification filed by Pertec Of Wisconsin, Inc. with the FDA for Oral Potential Meter (opm).
| Device ID | K982105 |
| 510k Number | K982105 |
| Device Name: | ORAL POTENTIAL METER (OPM) |
| Classification | Device, Caries Detection |
| Applicant | PERTEC OF WISCONSIN, INC. 10971 CLINIC RD. Suring, WI 54174 |
| Contact | Douglas L Cook |
| Correspondent | Douglas L Cook PERTEC OF WISCONSIN, INC. 10971 CLINIC RD. Suring, WI 54174 |
| Product Code | LFC |
| CFR Regulation Number | 872.1740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-16 |
| Decision Date | 1998-09-16 |