Oral Potential Meter (Opm)

FDA 510(k) K982105 · Pertec of Wisconsin, Inc.

Substantially Equivalent

510(k) numberK982105

Submission

Device name
Oral Potential Meter (Opm)
Applicant
Pertec of Wisconsin, Inc.
Suring, WI, US
Received
June 16, 1998
Decision date
September 16, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
LFC – Device, Caries Detection
Device class
Class II (moderate risk)
Regulation
21 CFR 872.1740
Specialty
Dental

Other 510(k)s with product code LFC

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K193447Vista DyesLFC · Traditional Inter-Med/Vista Dental Products03/11/2020SE
K102821DiscovredLFC · Traditional Phoenix Dental, Inc.03/11/2011SE
K060330See-It Caries DetectorLFC · Traditional Ronvig Dental Mfg. A/S04/07/2006SE
K030807Caries IndicatorLFC · Traditional Confi-Dental Products Co.06/09/2003SE
K012733Caries DetectorLFC · Traditional Kuraray Medical, Inc.09/14/2001SE
K994368American Dental Products Caries-Detector PlusLFC · Traditional American Dental Products, Inc.03/14/2000SE
K973200Caries StainLFC · Traditional Parkell, Inc.11/06/1997SE
K964430Pulpdent SnoopLFC · Traditional Pulpdent Corp.01/17/1997SE

Questions and answers

When was Oral Potential Meter (Opm) cleared by the FDA?

Oral Potential Meter (Opm) (K982105) received a 510(k) decision of Substantially Equivalent on September 16, 1998, 92 days after the submission was received.

What is the product code of K982105?

The FDA product code is LFC – Device, Caries Detection, a Class II (moderate risk) device regulated under 21 CFR 872.1740.