PANA SPRAY Plus

Handpiece, Air-powered, Dental

NAKANISHI, INC.

The following data is part of a premarket notification filed by Nakanishi, Inc. with the FDA for Pana Spray Plus.

Pre-market Notification Details

Device IDK163483
510k NumberK163483
Device Name:PANA SPRAY Plus
ClassificationHandpiece, Air-powered, Dental
Applicant NAKANISHI, INC. 700 Shimohinata Kanuma-shi,  JP 322-8666
ContactKimihiko Satoh
CorrespondentDiane Rutherford
KEN BLOCK CONSULTING 1201 RICHARDSON DRIVE, SUITE 160 Richardson,  TX  75080
Product CodeEFB  
CFR Regulation Number872.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-12-12
Decision Date2017-08-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04560224991080 K163483 000
04560264538566 K163483 000
04589551356454 K163483 000
04589551356447 K163483 000
04589551356430 K163483 000
04589551392063 K163483 000
04560264502970 K163483 000
04560264502963 K163483 000
04589551393367 K163483 000

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