Park Dental Research Aligners

Aligner, Sequential

Park Dental Research Corporation

The following data is part of a premarket notification filed by Park Dental Research Corporation with the FDA for Park Dental Research Aligners.

Pre-market Notification Details

Device IDK180648
510k NumberK180648
Device Name:Park Dental Research Aligners
ClassificationAligner, Sequential
Applicant Park Dental Research Corporation 2401 N. Commerce St Suite E Ardmore,  OK  73401
ContactRonald A. Bulard
CorrespondentAngela Blackwell
Blackwell Device Consulting P.O. Box 718 Gresham,  OR  97030 -0172
Product CodeNXC  
CFR Regulation Number872.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-03-13
Decision Date2019-01-08

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