DENTAL INSTRUMENTS - CUTTING INSTRUMENT

Instrument, Hand, Calculus Removal

MILTEX, INC.

The following data is part of a premarket notification filed by Miltex, Inc. with the FDA for Dental Instruments - Cutting Instrument.

Pre-market Notification Details

Device IDK823326
510k NumberK823326
Device Name:DENTAL INSTRUMENTS - CUTTING INSTRUMENT
ClassificationInstrument, Hand, Calculus Removal
Applicant MILTEX, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeELA  
CFR Regulation Number872.4565 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-11-08
Decision Date1982-11-24

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