PERIO PROTECT TRAY

Tray, Fluoride, Disposable

PERIO PROTECT LLC

The following data is part of a premarket notification filed by Perio Protect Llc with the FDA for Perio Protect Tray.

Pre-market Notification Details

Device IDK031809
510k NumberK031809
Device Name:PERIO PROTECT TRAY
ClassificationTray, Fluoride, Disposable
Applicant PERIO PROTECT LLC 1625 MASSACHUSETTS AVENUE NW; SUITE 300 Washington,  DC  20036 -2247
ContactDavid L Rosen
CorrespondentDavid L Rosen
PERIO PROTECT LLC 1625 MASSACHUSETTS AVENUE NW; SUITE 300 Washington,  DC  20036 -2247
Product CodeKMT  
CFR Regulation Number872.6870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-06-12
Decision Date2004-01-23
Summary:summary

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