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HIOSSEN, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30174501593017450159HIOSSEN, INC.1N2026-01-0156-58A East Bridge Street Morrisville PA US 19067
30311621233031162123Hiossen, Inc.1N2026-01-016940 Beach Blvd Building D Unit D-709 Buena Park CA US 90621

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2791991181270272K240688RODIN Titan 3D ResinEBI2024-06-20
3289011163398628K233389EK Digital AbutmentsNHA2024-05-29
2791991163398628K233389EK Digital AbutmentsNHA2024-05-29
2791991777574921K171585LUXEN Zr, LUXEN SmileEIH2018-10-31
2791991522048323K123627ET SMARTFIT ABUTMENTNHA2013-06-28
3289011522048323K123627ET SMARTFIT ABUTMENTNHA2013-06-28
2791991121676517
2791991220817451

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NHA42024-05-29
EBI12024-06-20
EIH12018-10-31

PMN#

GUDID#

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