FDA.reportPublic FDA data

HIOSSEN INC.

Matched from indexed company URL: HIOSSEN, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30071354423007135442HIOSSEN INC.1N2026-01-0185 BEN FAIRLESS DR Fairless Hills PA US 19030
30101856353010185635HIOSSEN INC.1Y2026-01-0150 Maple Street Norwood NJ US 07648
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
908231834476994K251427EK MULTI ANGLED 30 ABUTMENTNHA2026-01-29
908231968016482K241003HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)NHA2025-01-08
2791991181270272K240688RODIN Titan 3D ResinEBI2024-06-20
908231789525656K240232EK D3.3 and Ultra Wide ImplantsDZE2024-09-13
3289011163398628K233389EK Digital AbutmentsNHA2024-05-29
2791991163398628K233389EK Digital AbutmentsNHA2024-05-29
908231163398628K233389EK Digital AbutmentsNHA2024-05-29
908231818069983K233194TS Abutment SystemNHA2024-02-20
908232057167778K222636ET Abutment SystemNHA2023-04-28
908231556273627K203360EK Implants and Abutments SystemDZE2022-01-07
908231932673448K191751EM ProvisionalDZE2019-12-16
908231348605723K191201EM SA Implant SystemDZE2019-11-15
908231806138509K183242ET IV SA Dental ImplantsDZE2019-05-21
908231281673271K182091Osstem Abutment SystemNHA2019-07-12
2066481938466065K180527IS3EKX2018-05-16
2066481403186446K173905Surgic Pro, Surgic Pro+EBW2018-06-19
2791991777574921K171585LUXEN Zr, LUXEN SmileEIH2018-10-31
908231409785817K170421ET Hybrid AbutmentNHA2018-01-11
908231338719581K161689OSSTEM Implant System - AbutmentNHA2017-05-22
908231470882653K153332ETIII SA Fixture System (O3.2mm)DZE2016-10-27
908231573701772K151626ET III Bio-SA Fixture SystemDZE2016-07-21
908231400879499K151542A-OssNPM2016-08-03
908231205491102K140934HIOSSEN IMPLANT SYSTEMDZE2014-11-12
908231793814604K140507HIOSSEN PROSTHETIC SYSTEMNHA2014-08-20
2791991522048323K123627ET SMARTFIT ABUTMENTNHA2013-06-28
3289011522048323K123627ET SMARTFIT ABUTMENTNHA2013-06-28
908231522048323K123627ET SMARTFIT ABUTMENTNHA2013-06-28
908231700925765K123471ETII SA FIXTURE SYSTEMDZE2013-07-05
908231939610270K112532ET II BIO-SA FIXTURE SYSTEMDZE2012-08-06
908231011241661K110308PROSTHETIC SYSTEMNHA2011-10-03
908231556116747K103537ET III SA ULTRA WIDE SYSTEMDZE2011-03-10
908231651053332K101096HT III SA FIXTURE SYSTEMDZE2010-10-08
908231837802735K093889MODIFICATION TO: HG III ULTRA WIDE SYSTEMDZE2010-04-22
908231298435504K093352HG III FIXTURE SYSTEMDZE2009-11-24
908231628304958K090237HG II FIXTURE SYSTEMDZE2009-04-17
908231145107960K083067MS SYSTEMDZE2009-02-02
908231606501698K082213GS III FIXTURE SYSTEMDZE2008-10-14
908231869506806K080387HU II / HS II FIXTURE SYSTEMDZE2008-03-07
908231167694555K073465US/GS ULTRA WIDE SYSTEMDZE2008-04-07
908231301458375K073247US/SS/GS SYSTEMDZE2008-03-07
908231980942242K072959MS SYSTEM (DENTURE)DZE2008-02-04
908231298864725
908231617339623
2791991121676517
908231220817451
2791991220817451

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DZE212024-09-13
NHA152026-01-29
EBI12024-06-20
EIH12018-10-31
EBW12018-06-19
EKX12018-05-16
NPM12016-08-03

PMN#

IS3

2018-05-16

Hiossen, Inc.

A-Oss

2016-08-03

HIOSSEN INC.

GUDID#

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