Cleared Traditional

DENTAL INSTRUMENTS SCALER

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

About This 510(k) Submission

K931330 is an FDA 510(k) clearance for the DENTAL INSTRUMENTS SCALER, a Scaler, Periodontic (Class I — General Controls, product code EMN), submitted by Minnesota Prophy Power, Inc. (Lakeville, US). The FDA issued a Cleared decision on January 26, 1994, 316 days after receiving the submission on March 16, 1993. This device falls under the Dental review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number K931330 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code EMN — Scaler, Periodontic
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4565