April Lee

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30037789293003778929April Lee1N2026-01-01106 Superior Irvine CA US 92620
30070310983007031098April Lee1N2026-01-01106 Superior Irvine CA US 92620
30083096543008309654April Lee1N2026-01-01106 Superior Irvine CA US 92620
30096401883009640188April Lee1N2026-01-01106 Superior Irvine CA US 92620
30125644473012564447April Lee1N2026-01-01106 Superior Irvine CA US 92620
30132713803013271380April Lee1N2026-01-01106 Superior Irvine CA US 92620
30153756473015375647April Lee1N2026-01-01106 Superior Irvine CA US 92620
30181599693018159969April Lee1N2026-01-01106 Superior Irvine CA US 92620
30213892533021389253April Lee1N2026-01-01106 Superior Irvine CA US 92620
30248592043024859204April Lee1N2026-01-01106 Superior Irvine CA US 92620
30314931193031493119April Lee1N2026-01-01106 Superior Irvine CA US 92620
00April Lee5N2020-04-25106 Superior Irvine CA US 92620
30121911153012191115April Lee1N2020-04-25106 Superior Irvine CA US 92620
30145790863014579086April Lee1N2020-04-25106 Superior Irvine CA US 92620
30154262083015426208April Lee1N2020-04-25106 Superior Irvine CA US 92620
30164457783016445778April Lee1N2020-04-25106 Superior Irvine CA US 92620
30166907683016690768April Lee1N2020-04-25106 SUPERIOR Irvine CA US 92620

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
877431526892969K253493Dentis SQ-SL AXEL FixtureDZE2026-03-04
3290651140172347K253334ZENEX Implant System_Short (R-System)DZE2026-03-16
877431070942533K241063s-Clean ScanHealing AbutmentNHA2024-07-25
3290651022711500K240560ZENEX Implant System_LongDZE2024-10-30
877431073159711K240511Dentis s-Clean SQ-SL FixtureDZE2024-05-20
877431892590140K233544MESHEETNXC2024-02-22
3290651540432989K233163ZENEX Implant System_ShortDZE2023-12-19
3290651757887141K232170Ti Link AbutmentNHA2024-01-12
3290651748831231K231557ZENEX FreeMilling & CCM Cast AbutmentNHA2023-08-24
3290651923386927K230630ZENEX Implant System_NarrowDZE2023-07-31
877431565553050K230523s-Clean Link Abutment NarrowNHA2023-05-24
877431594960410K230307Dentis i-Clean SystemNHA2023-07-11
877431284980268K230246Dentis s-Clean SQ-SL Narrow Implant SystemNHA2023-05-25
877431204653882K230203Dentis I-FIX AbutmentNHA2023-05-03
877431827468134K230126Dentis s-Clean Regular AbutmentNHA2023-08-04
877431898595525K222976MU SystemNHA2023-01-12
877431479600076K222913s-Clean Link AbutmentNHA2023-01-13
2004861833312191K222707IH Implant SystemDZE2023-07-07
877431683256655K222451SAVE GBRNHA2023-02-07
877431211933258K222367SAVE GBRDZL2023-03-23
1165371707435830K220517IBS SystemDZE2022-12-20
877431384721367K220440Dentis s-Clean Abutment MiniNHA2022-06-16
1165372029828174K220079Magicore Narrow SystemDZE2022-12-14
1165371060132281K212517Magicore SystemDZE2021-10-15
3290651242835240K211090ZENEX Implant SystemDZE2022-04-13
877431356262167K210410s-Clean Pre-Milled Abutment MiniNHA2021-09-10
877431044680186K210362s-Clean Pre-Milled AbutmentNHA2021-08-19
877431542259624K210134Dentis s-Clean s-LineDZE2021-04-19
877431588880077K210132s-Clean SQ-SL Implant System RegularDZE2021-02-17
877431146798162K210080Dentis s-Clean s-Line MiniDZE2021-06-04
1165371852086518K203344Premilled Titanium Block SystemNHA2021-08-25
877431672534534K202773s-Clean SQ-SL Implant System MiniDZE2021-03-18
1165371511881200K202479IBS Implant SystemDZE2020-09-23
1165371218926032K202418Magic UCLA Abutment SystemNHA2020-12-03
1165371650946861K201981Magicore SystemDZE2020-08-27
1165371119912978K201621Magicore II SystemNHA2020-07-15
1165371195562907K200753IBS Implant System IINHA2020-06-09
877431515646301K200099s-Clean SQ-SL Implant System MiniDZE2020-04-13
877431291345104K192688s-Clean SQ-SL Implant System RegularDZE2020-02-04
1165371921891840K192197Magicore II SystemDZE2020-04-28
2326461815448578K182814Rael TamponHEB2019-07-15
877431788437747K180657Resin for Temporary Crown & BridgeEBG2018-12-07
1165371082177440K173120CCM Abutment SystemNHA2018-03-16
877432005064885K171694s-Clean TiN Coating AbutmentsNHA2017-11-29
877431670088781K171027Dentis Dental Implant SystemDZE2017-09-06
877431313961759K170220OneQ-SL s-Clean Implant SystemDZE2017-04-27
1165371809246469K162099IBS Implant System IIDZE2017-02-15
877431194238294K161244s-Clean OneQ-SL Narrow Implant SystemDZE2016-12-07
877431743230163K160213s-Clean Tapered II RBM Implant SystemDZE2016-06-21
877431555511551K153639OneQ-SL s-Clean Implant SystemDZE2016-04-08
2004861927687219K153521IH Implant SystemDZE2016-10-14
1165371285284958K153350IBS Implant SystemDZE2016-05-09
1165371610989977K152520Magicore SystemDZE2016-01-25
877431732180164K150344Dentis Dental Implant SystemDZE2015-07-24
877431563993128K142313OneQ-SL Implant SystemDZE2015-12-10
1165371744913431K140806IBS IMPLANT SYSTEMDZE2015-03-23
3100711371314649K132956U FIT DENTAL IMPLANT SYSTEMDZE2014-06-05
877431542318271K111364HAPTITE COATING IMPLANT SYSTEMDZE2012-02-01
877431273455567K083586I-FIX SYSTEMDZE2009-04-29
877431340478369K083569SURGYBONEDZI2009-04-01
877431180408113K082843MODIFICATON TO: DENTIS DENTAL IMPLANT SYSTEMDZE2009-06-19
877431130631516K073486DENTIS DENTAL IMPLANT SYSTEMDZE2008-04-04
877431920987235K073486DENTIS DENTAL IMPLANT SYSTEMDZE2008-04-04
1165371046691076
2431391069529441
2547451191076488
2385931257075007
2378741670466998
2326461763996580
1861451923448064
2403192039552180
2326461105850841
3100711130651451
3008651150283999
208901215414310
877431288940360
877431304741758
2326461320023989
2004861331702892
1165371399173494
208901455581001
1165371463062677
2811801475933751
2326461485658535
2326461529287519
3008651534907990
2326461559883309
3008651567478104
3008651587216848
877431622867022
2899711628140602
3008651645607746
2004861686506726
1165371717482881
3330481731576529
208901747598224
3290651767323141
2004861796209394
208901935077331
1165371939700916
3290651999954425
2004862019759579
2326462023432010

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DZE382026-03-16
NHA202024-07-25
NXC12024-02-22
DZL12023-03-23
HEB12019-07-15
EBG12018-12-07
DZI12009-04-01