Cleared Traditional

DENTAL INSTRUMENTS CURETTE PERIODONTAL (K931329) - FDA 510(k) Clearance

Class I Dental device.

K931329 · Minnesota Prophy Power, Inc. · Dental device
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Jan 1994
Decision
317d
Days
Class 1
Risk

K931329 is an FDA 510(k) clearance for the DENTAL INSTRUMENTS CURETTE PERIODONTAL. Classified as Curette, Periodontic (product code EMS), Class I - General Controls.

Submitted by Minnesota Prophy Power, Inc. (Lakeville, US). The FDA issued a Cleared decision on January 27, 1994 after a review of 317 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - 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. Elevated predicate reliance profile. 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 Minnesota Prophy Power, Inc. devices

Submission Details

510(k) Number K931329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1993
Decision Date January 27, 1994
Days to Decision 317 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
190d slower than avg
Panel avg: 127d · This submission: 317d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EMS Curette, Periodontic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.