FDA.report

DIOPSYS INC.

Matched from indexed company URL: DIO Corporation

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30041744673004174467DIOPSYS INC.1N2026-01-011000 Kreider Drive STE 700 Middletown PA US 17057
30064001053006400105DIO USA1Y2026-01-011932 E Deere Ave Ste 100 Santa Ana CA US 92705
30071267093007126709DIO Corporation1N2026-01-0166, Centumseo-ro Haeundae-gu Busan KR 48058
30073213673007321367DION LABEL PRINTING, INC.1N2026-01-01539 North Rd Westfield MA US 01085
30114130203011413020DIODE ART ENGINEERING DBA AIR RELAX1Y2026-01-01900 TURNBULL CANYON RD UNIT E04 City Industry CA US 91745
30254889933025488993Dion Snider1N2026-01-0190 Executive Dr Ste E Carmel IN US 46032
20247481000120742Dioptics Medical Products Inc.1Y2020-04-25500 George Washington Highway Smithfield RI US 02917
30041744673004174467DIOPSYS INC.1N2020-04-2516 CHAPIN ROAD SUITE 912 PINE BROOK NJ US 07058
30089585723008958572Dion Wu1N2020-04-254456 BALDWIN AV.EL MONTE, 91731 USA El Monte CA US 91731
30090146373009014637DIO MEDICAL CORPORATION1Y2020-04-252900 Potshop Ln Suite 200 Eagleville PA US 19403
30157818063015781806DIORCO CO., LTD.1N2020-04-25#401, Bong Bldg., 26 Yeongil-ro, Yeongtong 1-dong, Yeongtong-gu Suwon-si Gyeonggido KR 16706

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3375721125206488K241193AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.)JFB2025-01-31
251961657196528K220253Eco Abutment, Multiunit AbutmentNHA2023-08-18
1804251938192267K212491Air Relax Pro Model AR-4.0IRP2021-09-02
1804251501726582K211460Air Relax Plus Model AR-3.0IRP2021-05-25
251961860327887K210828DIOnavi-Denture02EBI2021-03-23
251961465093312K193623DIOnavi-DentureEBI2020-10-22
251961773422108K193404UF(II) Bar holder abutmentNHA2020-05-18
251961044463654K192263UCLA CCM AbutmentNHA2020-02-21
1804251525035636K191441Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0)IRP2021-03-05
251962017656980K190048UF(II) Anatomic abutmentNHA2019-09-30
251962056273328K190048UF(II) Anatomic abutmentNHA2019-09-30
251961758431276K182194UV Active Implant SystemDZE2018-12-14
251961885676500K181037DIO CAD/CAM AbutmentNHA2018-12-21
251961558416223K173975UF(II) Wide FixtureDZE2018-06-01
251961269561539K170608UF(II) Implant SystemDZE2018-03-30
251961256133709K161987UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - SuprastructureDZE2017-02-21
251961625037025K142358Osstell IDxEKX2015-02-19
251961483241319K141570IMPLANT STUDIOLLZ2014-10-31
251961101062664K123695TRAUS SIP10EKY2012-12-18
251961273798707K122519DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEMDZE2013-05-21
251962034690089K112746DIOSLIMON IMPLANT SYSTEMDZE2011-10-21
236411365623913K101763DIOPSYS NOVA VEP VISION TESTING SYSTEMGWE2011-05-09
3426111902780782K101763DIOPSYS NOVA VEP VISION TESTING SYSTEMGWE2011-05-09
251961671188922K100100DIO STEADY EXTERNAL IMPLANT SYSTEMDZE2010-11-10
251961915961237K092758X-CUBEEBW2009-09-21
251961794029710K080559DIO SM IMPLANT SYSTEMDZE2008-10-09
251961560114316K080129SECURE IMPLANT SYSTEM (2.5/3.0MM)DZE2008-05-30
251961631597568K080128SM-EXTRA WIDE (RBM) IMPLANT SYSTEMDZE2008-05-14
251961425241506K080126DIO PROTEM IMPLANT SYSTEMDZE2008-04-11
251961624594962K073070DIO BIOTITE-H IMPLANT SYSTEMDZE2008-05-16
251961084775712K070570DIO IMPLANT SYSTEMDZE2008-04-15
251961185002163K070569SM INTERNAL./EXTERNAL IMPLANT SYSTEMDZE2007-11-08
251961230589491K070568DIO PROTEM IMPLANT SYSTEMDZE2007-05-25
251961534864624K061797SM IMPLANT SYSTEMSDZE2006-09-01
236411044692674K043491ENFANTTMGWE2005-03-16
1573561195296618
2329561331674352
1272201648281509
1272201648551724
1272201666572894
1272201701606051
1272201970597421
251961970774993
251961126336738
1573561184427751
1573561216144549
251961300121032
251961307862474
251961319692987
3375721389069985
3375721397936307
251961419769373
251961539691815
251961553412809
251961579452187
251961966953167
251961977050157
251961996425694

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
DZE162018-12-14
NHA62023-08-18
IRP32021-09-02
GWE32011-05-09
EBI22021-03-23
JFB12025-01-31
EKX12015-02-19
LLZ12014-10-31
EKY12012-12-18
EBW12009-09-21

PMN

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