DENTAL INSTRUMENTS SCALER

Scaler, Periodontic

MINNESOTA PROPHY POWER, INC.

The following data is part of a premarket notification filed by Minnesota Prophy Power, Inc. with the FDA for Dental Instruments Scaler.

Pre-market Notification Details

Device IDK931330
510k NumberK931330
Device Name:DENTAL INSTRUMENTS SCALER
ClassificationScaler, Periodontic
Applicant MINNESOTA PROPHY POWER, INC. 11538 172ND ST. Lakeville,  MN  55044
ContactRoselyn R Wilson
CorrespondentRoselyn R Wilson
MINNESOTA PROPHY POWER, INC. 11538 172ND ST. Lakeville,  MN  55044
Product CodeEMN  
CFR Regulation Number872.4565 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-03-16
Decision Date1994-01-26

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