HT III SA FIXTURE SYSTEM

Implant, Endosseous, Root-form

HIOSSEN INC.

The following data is part of a premarket notification filed by Hiossen Inc. with the FDA for Ht Iii Sa Fixture System.

Pre-market Notification Details

Device IDK101096
510k NumberK101096
Device Name:HT III SA FIXTURE SYSTEM
ClassificationImplant, Endosseous, Root-form
Applicant HIOSSEN INC. 85 BEN FAIRLESS DRIVE Fairless Hills,  PA  19030
ContactPatrick Lim
CorrespondentPatrick Lim
HIOSSEN INC. 85 BEN FAIRLESS DRIVE Fairless Hills,  PA  19030
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-04-20
Decision Date2010-10-08
Summary:summary

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