Cleared Traditional

K931330 - DENTAL INSTRUMENTS SCALER

K931330 is an FDA 510(k) clearance for DENTAL INSTRUMENTS SCALER, manufactured by Minnesota Prophy Power, Inc.. The device is a Class 1 Dental device with product code EMN cleared through the Traditional 510(k) pathway after a 316-day FDA review.

K931330 · Minnesota Prophy Power, Inc. · Dental device
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Jan 1994
Decision
316d
Days
Class 1
Risk

K931330 is an FDA 510(k) clearance for the DENTAL INSTRUMENTS SCALER. Classified as Scaler, Periodontic (product code EMN), Class I - General Controls.

Submitted by Minnesota Prophy Power, Inc. (Lakeville, US). The FDA issued a Cleared decision on January 26, 1994 after a review of 316 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 - K931330

510(k) Number K931330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1993
Decision Date January 26, 1994
Days to Decision 316 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
189d slower than avg
Panel avg: 127d · This submission: 316d
Pathway characteristics
Predicate-based equivalence.

EMN Device Classification - Class 1, General Controls

Product Code EMN Scaler, 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 - EMN Scaler, Periodontic

Devices cleared under the same product code (EMN) and FDA review panel - the closest regulatory comparables to K931330.
PLAQUE SCRAPER-A INTERPROXIMAL (BETWEEN TEETH) PLAQUE REMOVER, MODEL Z01, Z02
K070127 · Kevin Vu, Dds · Mar 2007
1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS
K851721 · Artiberia · Jul 1985
BEACH SCALERS
K821786 · Pacific Dental Corp. · Jul 1982
PERIODONTAL INSTRUMENT #21 GOLDMAN-FOX
K781035 · Premier Dental Products Co. · Jun 1978