Skip to content
FDA.report
Public FDA data
NDC
RxNorm
DailyMed
Applications
GUDID
GMDN
PMA
PMN
MAUDE
Recalls
Search FDA.report
Search
Home
Company-Registration
1777574921
Device Listing 1777574921
Listing Summary
#
Listing key
1777574921
Premarket submission
K171585
Device
LUXEN Zr, LUXEN Smile
Applicant
Dentalmax Co., Ltd.
Product code
EIH
Decision date
2018-10-31
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
279199
3017450159
3017450159
HIOSSEN, INC.
1
N
2026-01-01
56-58A East Bridge Street Morrisville PA US 19067