ALPHA AIR HANDPIECE, ULTRA-PUSH, AL-SU, AL-MU, AL-TU

Handpiece, Air-powered, Dental

NSK NAKANISHI, INC.

The following data is part of a premarket notification filed by Nsk Nakanishi, Inc. with the FDA for Alpha Air Handpiece, Ultra-push, Al-su, Al-mu, Al-tu.

Pre-market Notification Details

Device IDK962543
510k NumberK962543
Device Name:ALPHA AIR HANDPIECE, ULTRA-PUSH, AL-SU, AL-MU, AL-TU
ClassificationHandpiece, Air-powered, Dental
Applicant NSK NAKANISHI, INC. 340 KAMIHINATA,KANUMA-SHI Tochigi-ken,  JP 322
ContactHiroji Sekiguchi
CorrespondentHiroji Sekiguchi
NSK NAKANISHI, INC. 340 KAMIHINATA,KANUMA-SHI Tochigi-ken,  JP 322
Product CodeEFB  
CFR Regulation Number872.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-06-28
Decision Date1996-09-11

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