SPRAY & CLEAN HANDPIECE CLEANER& LUBRICANT MAXIMA HANDPIECE CLEANER & LUBRICANT EZCARE HANDPIECE CLEANER & LUBRICANT

Handpiece, Air-powered, Dental

HANDPIECE HEADQUARTERS INC. - HPR INC.

The following data is part of a premarket notification filed by Handpiece Headquarters Inc. - Hpr Inc. with the FDA for Spray & Clean Handpiece Cleaner& Lubricant Maxima Handpiece Cleaner & Lubricant Ezcare Handpiece Cleaner & Lubricant.

Pre-market Notification Details

Device IDK113674
510k NumberK113674
Device Name:SPRAY & CLEAN HANDPIECE CLEANER& LUBRICANT MAXIMA HANDPIECE CLEANER & LUBRICANT EZCARE HANDPIECE CLEANER & LUBRICANT
ClassificationHandpiece, Air-powered, Dental
Applicant HANDPIECE HEADQUARTERS INC. - HPR INC. 620 S. PLACENTIA AVE Placentia,  CA  92870
ContactTina Steffanie-oak
CorrespondentTina Steffanie-oak
HANDPIECE HEADQUARTERS INC. - HPR INC. 620 S. PLACENTIA AVE Placentia,  CA  92870
Product CodeEFB  
CFR Regulation Number872.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-12-14
Decision Date2012-04-05
Summary:summary

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