FDA.report

Ormco Corporation

Matched from indexed company URL: Ormco Corp.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30135086702024258Ormco Corporation1N2026-01-011937 W. Mission Blvd. Pomona CA US 91766
30152729493015272949Ormco Corporation1Y2026-01-01200 S. Kraemer Blvd -- Brea CA US 92821
20161502016150Ormco Corporation, also trading as SybronEndo1Y2020-04-251332 S Lone Hill Ave Glendora CA US 91740

GUDID Contact Samples

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDIDProductPhoneEmail
00889989073140Tubli-Seal - Root Canal Sealer 1 Tube each - Catalyst (5g) and Base (15g)+18005377123EndoRotaryCustCare@kerrdental.com
00889989073157Tubli-Seal - Root Canal Sealer - BULK PK24 ( Catalyst (5g) and Base (15g) each)+18005377123EndoRotaryCustCare@kerrdental.com
00889989074116Sealapex - Root Canal Sealer (1 Tube each - Catalyst (18g) and Base (12g))+18005377123EndoRotaryCustCare@kerrdental.com

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
169741433148363K990682PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.)EKX1999-03-24
169741390104932K990225ENDO ANALYZER, MODEL 8005, MODIFIEDEAT1999-02-25
169741161534312K984217ENLIGHT-2DYH1999-01-20
2070051161534312K984217ENLIGHT-2DYH1999-01-20
2268721161534312K984217ENLIGHT-2DYH1999-01-20
169741339377657K980195FACEBOWDZB1998-03-11
2070051339377657K980195FACEBOWDZB1998-03-11
2268721339377657K980195FACEBOWDZB1998-03-11
169741939354738K970715SYSTEM B HEAT SOURCEEAT1997-04-07
169741848577616K963862TOUCH N' HEATEAT1996-12-02
169741443680802K962540E-TYPE CONTRA ANGLE NAC-EEGS1996-09-12
169741229155797K943245SPIRIT MBDYW1994-08-23
2070051229155797K943245SPIRIT MBDYW1994-08-23
2268721229155797K943245SPIRIT MBDYW1994-08-23
169741330164806K942393TUBLI-SEAL EWTKIF1994-06-10
169741849795746K941015ORMCO SYSTEM 1+ (TM)DYH1994-03-31
2070051849795746K941015ORMCO SYSTEM 1+ (TM)DYH1994-03-31
2268721849795746K941015ORMCO SYSTEM 1+ (TM)DYH1994-03-31
169741160788427K934714ENDODONTIC PULP CANAL SPREADERELC1994-02-14
169741998637346K923556ADP FACEMASKDZB1992-12-04
2070051998637346K923556ADP FACEMASKDZB1992-12-04
2268721998637346K923556ADP FACEMASKDZB1992-12-04
169741821428602K902646HOOD GEAR (TM) BREAKAWAY HEADGEAR WITH NECK STRAPDZB1990-09-06
2070051821428602K902646HOOD GEAR (TM) BREAKAWAY HEADGEAR WITH NECK STRAPDZB1990-09-06
2268721821428602K902646HOOD GEAR (TM) BREAKAWAY HEADGEAR WITH NECK STRAPDZB1990-09-06
169741990811308K902645HOOD GEAR (TM) BREAKAWAY HEADGEAR W/ HIGH PULLDZB1990-09-06
2070051990811308K902645HOOD GEAR (TM) BREAKAWAY HEADGEAR W/ HIGH PULLDZB1990-09-06
2268721990811308K902645HOOD GEAR (TM) BREAKAWAY HEADGEAR W/ HIGH PULLDZB1990-09-06
169741765582596K895386GLASIONEMA1990-04-16
2070051765582596K895386GLASIONEMA1990-04-16
2268721765582596K895386GLASIONEMA1990-04-16
169741996832145K871591ORMCO GEL-ETCHDYH1987-05-18
2070051996832145K871591ORMCO GEL-ETCHDYH1987-05-18
2268721996832145K871591ORMCO GEL-ETCHDYH1987-05-18
169741411207988K862538SENTRY BREAKWAY NECK STRAPDZB1986-07-11
2070051411207988K862538SENTRY BREAKWAY NECK STRAPDZB1986-07-11
2268721411207988K862538SENTRY BREAKWAY NECK STRAPDZB1986-07-11
169741860030203K843023KERR PORCELAIN REPAIR PRIMERKLE1984-10-25
2070051860030203K843023KERR PORCELAIN REPAIR PRIMERKLE1984-10-25
2268721860030203K843023KERR PORCELAIN REPAIR PRIMERKLE1984-10-25
2070051835048545K250487SparkTM Clear Aligner SystemNXC2025-02-20
2268721835048545K250487SparkTM Clear Aligner SystemNXC2025-02-20
2070051551912776K250015Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree AdhesiveDYH2025-01-03
2268721551912776K250015Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree AdhesiveDYH2025-01-03
2070051453048818K203737Spark Clear Aligner SystemNXC2021-03-22
2268721453048818K203737Spark Clear Aligner SystemNXC2021-03-22
169741330944091K182826Ormco Spark Aligner SystemNXC2018-10-11
2070051330944091K182826Ormco Spark Aligner SystemNXC2018-10-11
2268721330944091K182826Ormco Spark Aligner SystemNXC2018-10-11
169741622023480K172845Symetri ClearNJM2018-01-31
2070051622023480K172845Symetri ClearNJM2018-01-31
2268721622023480K172845Symetri ClearNJM2018-01-31
169741456964268K171844Inspire ICE aka Inspire ICE Clear BracketsNJM2017-07-18
2070051456964268K171844Inspire ICE aka Inspire ICE Clear BracketsNJM2017-07-18
2268721456964268K171844Inspire ICE aka Inspire ICE Clear BracketsNJM2017-07-18
2268721929762712K163317ELECTROmaticEBW2017-02-21
169741627082146K153067Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT XpressKIF2016-07-27
169741153692828K152959Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringesKIF2016-04-14
169741118373774K152956Pulp Canal Sealer, Pulp Canal Sealer EWTKIF2016-05-06
169741674556296K141611LYTHOS DIGITAL IMPRESSION SYSTEMNOF2014-12-05
2070051674556296K141611LYTHOS DIGITAL IMPRESSION SYSTEMNOF2014-12-05
2268721674556296K141611LYTHOS DIGITAL IMPRESSION SYSTEMNOF2014-12-05
169741111154873K140685ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEMNYL2014-07-02
169741060822142K123416INSIGNIA WITH ITERODYW2013-03-13
2070051060822142K123416INSIGNIA WITH ITERODYW2013-03-13
2268721060822142K123416INSIGNIA WITH ITERODYW2013-03-13
169741798812687K123118INSIGNIA DIGICASTDYW2013-03-26
2070051798812687K123118INSIGNIA DIGICASTDYW2013-03-26
2268721798812687K123118INSIGNIA DIGICASTDYW2013-03-26
169741395280209K122065DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USENOF2013-02-08
2070051395280209K122065DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USENOF2013-02-08
2268721395280209K122065DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USENOF2013-02-08
169741247132746K121524INSIGNIADYW2012-08-09
2070051247132746K121524INSIGNIADYW2012-08-09
2268721247132746K121524INSIGNIADYW2012-08-09
169741407016392K093208SIMPLISEALKIF2010-02-12
169741285481513K081415DAMON 4CLEARNJM2008-09-24
2070051285481513K081415DAMON 4CLEARNJM2008-09-24
2268721285481513K081415DAMON 4CLEARNJM2008-09-24
169741254584256K062856TF ROTARY NICKEL TITANIUM FILEEKS2006-12-13
169741332137240K061481GRENGLOODYH2006-07-06
2070051332137240K061481GRENGLOODYH2006-07-06
2268721332137240K061481GRENGLOODYH2006-07-06
169741196640679K061230VECTORS TEMPORARY ANCHORAGE SYSTEMOAT2006-08-03
2070051196640679K061230VECTORS TEMPORARY ANCHORAGE SYSTEMOAT2006-08-03
2268721196640679K061230VECTORS TEMPORARY ANCHORAGE SYSTEMOAT2006-08-03
169742043016960K052477DAMON 3 MODIFIEDDYW2005-11-30
2070052043016960K052477DAMON 3 MODIFIEDDYW2005-11-30
2268722043016960K052477DAMON 3 MODIFIEDDYW2005-11-30
169741969939290K042422D3 CHROMADYH2004-11-15
2070051969939290K042422D3 CHROMADYH2004-11-15
2268721969939290K042422D3 CHROMADYH2004-11-15
169741283189459K032407OPTIBAND LCDYH2003-10-06
2070051283189459K032407OPTIBAND LCDYH2003-10-06
2268721283189459K032407OPTIBAND LCDYH2003-10-06
169741343169939K031664ELEMENTS OBTURATION UNITEKR2004-04-28
169741407778299K024198SMEARCLEARKJJ2003-03-05
169741236161754K023819FIBERFILL SGPEKM2003-03-26
169741928524215K021298ELEMENTS DIAGNOSTIC UNITEAT2002-06-19
169742037629364K020502SOLO ORTHO 3DYH2002-05-01
2070052037629364K020502SOLO ORTHO 3DYH2002-05-01
2268722037629364K020502SOLO ORTHO 3DYH2002-05-01
169741049915184K001881IMPROVED ENLIGHT LVDYH2000-08-22
2070051049915184K001881IMPROVED ENLIGHT LVDYH2000-08-22
2268721049915184K001881IMPROVED ENLIGHT LVDYH2000-08-22
169741093710454
169741094649693
2268721094649693
169741112708164
169741137683035
2268721137683035
169741139120057
169741183124001
169741185010824
2268721185010824
169741203181891
169741215676021
169741257205741

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
DYH262025-01-03
DYW162013-03-26
DZB151998-03-11
NJM102018-01-31
NXC72025-02-20
NOF62014-12-05
KIF52016-07-27
EAT42002-06-19
OAT32006-08-03
EMA31990-04-16
KLE31984-10-25
EBW12017-02-21
NYL12014-07-02
EKS12006-12-13
EKR12004-04-28
EKM12003-03-26
KJJ12003-03-05
EKX11999-03-24
EGS11996-09-12
ELC11994-02-14

PMN

44 records. Showing 1-40. Next

GUDID

80 records. Showing 1-40. Next