Cleared Traditional

K931329 - DENTAL INSTRUMENTS CURETTE PERIODONTAL

K931329 is an FDA 510(k) clearance for DENTAL INSTRUMENTS CURETTE PERIODONTAL, manufactured by Minnesota Prophy Power, Inc.. The device is a Class 1 Dental device with product code EMS cleared through the Traditional 510(k) pathway after a 317-day FDA review.

K931329 · Minnesota Prophy Power, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K931329

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.

EMS Device Classification - Class 1, General Controls

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.

Regulatory Peers - EMS Curette, Periodontic

Devices cleared under the same product code (EMS) and FDA review panel - the closest regulatory comparables to K931329.
CURRETTES, ALVEOLAR (MOLT AND MILLER)
K872091 · Military Engineering, Inc. · Jul 1987
CURETTE, PERIODONTAL, COLUMBIA UNIVERSITY
K870590 · Military Engineering, Inc. · Apr 1987
ELEVATOR - VARIOUS
K841011 · Premier Dental Products Co. · Jun 1984
DENTAL INSTRUMENTS - SCALERS
K823319 · Miltex, Inc. · Nov 1982
BEACH CURETTE NO. 2 AND NO. 3 T.G.
K821789 · Pacific Dental Corp. · Jul 1982