Cleared Traditional

K982105 - ORAL POTENTIAL METER (OPM)

K982105 is an FDA 510(k) clearance for ORAL POTENTIAL METER (OPM), manufactured by Pertec of Wisconsin, Inc.. The device is a Class 2 Dental device with product code LFC cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K982105 · Pertec of Wisconsin, Inc. · Dental device
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Sep 1998
Decision
92d
Days
Class 2
Risk

K982105 is an FDA 510(k) clearance for the ORAL POTENTIAL METER (OPM). Classified as Device, Caries Detection (product code LFC), Class II - Special Controls.

Submitted by Pertec of Wisconsin, Inc. (Suring, US). The FDA issued a Cleared decision on September 16, 1998 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.1740 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Pertec of Wisconsin, Inc. devices

FDA 510(k) Submission Details - K982105

510(k) Number K982105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1998
Decision Date September 16, 1998
Days to Decision 92 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 127d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LFC Device Classification - Class 2, Special Controls

Product Code LFC Device, Caries Detection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1740
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - LFC Device, Caries Detection

All 12
Devices cleared under the same product code (LFC) and FDA review panel - the closest regulatory comparables to K982105.
CARIES INDICATOR
K030807 · Confi-Dental Products Co. · Jun 2003
CARIES DETECTOR
K012733 · Kuraray Medical, Inc. · Sep 2001
AMERICAN DENTAL PRODUCTS CARIES-DETECTOR PLUS
K994368 · American Dental Products, Inc. · Mar 2000
CARIES STAIN
K973200 · Parkell, Inc. · Nov 1997
PULPDENT SNOOP
K964430 · Pulpdent Corp. · Jan 1997
TEAM CARIES INDICATOR
K963927 · Centrix, Inc. · Nov 1996