Maxima XTEND Handpiece Maintenance System

Handpiece, Air-powered, Dental

HANDPIECE HEADQUARTERS

The following data is part of a premarket notification filed by Handpiece Headquarters with the FDA for Maxima Xtend Handpiece Maintenance System.

Pre-market Notification Details

Device IDK143183
510k NumberK143183
Device Name:Maxima XTEND Handpiece Maintenance System
ClassificationHandpiece, Air-powered, Dental
Applicant HANDPIECE HEADQUARTERS 620 S. PLACENTIA AVE. Placentia,  CA  92870
ContactTimothy Ropchan
CorrespondentSonny Phung
HANDPIECE HEADQUARTERS 620 S. PLACENTIA AVE. Placentia,  CA  92870
Product CodeEFB  
CFR Regulation Number872.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-11-05
Decision Date2015-02-17
Summary:summary

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