HI-WAVE; POUR-PLUS

Resin, Denture, Relining, Repairing, Rebasing

DENPLUS, INC.

The following data is part of a premarket notification filed by Denplus, Inc. with the FDA for Hi-wave; Pour-plus.

Pre-market Notification Details

Device IDK011762
510k NumberK011762
Device Name:HI-WAVE; POUR-PLUS
ClassificationResin, Denture, Relining, Repairing, Rebasing
Applicant DENPLUS, INC. 1221 LABADIE, SUITE 205 Longueuil, Quebec,  CA J4n 1e2
ContactShuojia Dong
CorrespondentShuojia Dong
DENPLUS, INC. 1221 LABADIE, SUITE 205 Longueuil, Quebec,  CA J4n 1e2
Product CodeEBI  
CFR Regulation Number872.3760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-06-07
Decision Date2001-08-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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D8451151107 K011762 000
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D8451141102 K011762 000

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