PROPHY-MATE NEO

Handpiece, Air-powered, Dental

NAKANISHI, INC.

The following data is part of a premarket notification filed by Nakanishi, Inc. with the FDA for Prophy-mate Neo.

Pre-market Notification Details

Device IDK112673
510k NumberK112673
Device Name:PROPHY-MATE NEO
ClassificationHandpiece, Air-powered, Dental
Applicant NAKANISHI, INC. 1201 RICHARDSON DRIVE SUITE 280 Richardson,  TX  75080
ContactDiane Rutherford
CorrespondentDiane Rutherford
NAKANISHI, INC. 1201 RICHARDSON DRIVE SUITE 280 Richardson,  TX  75080
Product CodeEFB  
CFR Regulation Number872.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-09-14
Decision Date2012-02-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04560264572492 K112673 000
04560264572478 K112673 000
04560264572461 K112673 000
04560264572454 K112673 000
04589551383283 K112673 000
04560264574953 K112673 000
04589551382774 K112673 000
04560264507166 K112673 000

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