APEX 90

Alloy, Gold-based Noble Metal

WE DONG MYUNG DENTAL INDUSTRIAL CO., LTD.

The following data is part of a premarket notification filed by We Dong Myung Dental Industrial Co., Ltd. with the FDA for Apex 90.

Pre-market Notification Details

Device IDK030206
510k NumberK030206
Device Name:APEX 90
ClassificationAlloy, Gold-based Noble Metal
Applicant WE DONG MYUNG DENTAL INDUSTRIAL CO., LTD. 1733 CANTON LN. Marietta,  GA  30062
ContactRonald D Arkin
CorrespondentChan Yo Won
UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas,  WA  98607 -9526
Product CodeEJT  
CFR Regulation Number872.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2003-01-21
Decision Date2003-01-29
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.