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Ormco Corporation

FDA Registration(s)#

Registration, FEI, Name table
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

GUDID Contact Samples#

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

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00889989073140Tubli-Seal - Root Canal Sealer 1 Tube each - Catalyst (5g) and Base (15g)+18005377123EndoRotaryCustCare@kerrdental.com
00889989079494Tevdek II - Green Braided PTFE Impregnated Polyester Fiber - Nonabsorbable Surgical Suture+18005377123EndoRotaryCustCare@kerrdental.com
00889989079500Tevdek II - Green Braided PTFE Impregnated Polyester Fiber - Nonabsorbable Surgical Suture+18005377123EndoRotaryCustCare@kerrdental.com
00889989079517Tevdek II - Green Braided PTFE Impregnated Polyester Fiber - Nonabsorbable Surgical Suture+18005377123EndoRotaryCustCare@kerrdental.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2268721161534312K984217ENLIGHT-2DYH1999-01-20
2070051161534312K984217ENLIGHT-2DYH1999-01-20
2268721339377657K980195FACEBOWDZB1998-03-11
2070051339377657K980195FACEBOWDZB1998-03-11
2268721229155797K943245SPIRIT MBDYW1994-08-23
2070051229155797K943245SPIRIT MBDYW1994-08-23
2268721849795746K941015ORMCO SYSTEM 1+ (TM)DYH1994-03-31
2070051849795746K941015ORMCO SYSTEM 1+ (TM)DYH1994-03-31
2268721998637346K923556ADP FACEMASKDZB1992-12-04
2070051998637346K923556ADP FACEMASKDZB1992-12-04
2268721821428602K902646HOOD GEAR (TM) BREAKAWAY HEADGEAR WITH NECK STRAPDZB1990-09-06
2070051821428602K902646HOOD GEAR (TM) BREAKAWAY HEADGEAR WITH NECK STRAPDZB1990-09-06
2268721990811308K902645HOOD GEAR (TM) BREAKAWAY HEADGEAR W/ HIGH PULLDZB1990-09-06
2070051990811308K902645HOOD GEAR (TM) BREAKAWAY HEADGEAR W/ HIGH PULLDZB1990-09-06
2268721765582596K895386GLASIONEMA1990-04-16
2070051765582596K895386GLASIONEMA1990-04-16
2268721996832145K871591ORMCO GEL-ETCHDYH1987-05-18
2070051996832145K871591ORMCO GEL-ETCHDYH1987-05-18
2268721411207988K862538SENTRY BREAKWAY NECK STRAPDZB1986-07-11
2070051411207988K862538SENTRY BREAKWAY NECK STRAPDZB1986-07-11
2268721860030203K843023KERR PORCELAIN REPAIR PRIMERKLE1984-10-25
2070051860030203K843023KERR PORCELAIN REPAIR PRIMERKLE1984-10-25
2070051835048545K250487SparkTM Clear Aligner SystemNXC2025-02-20
2268721835048545K250487SparkTM Clear Aligner SystemNXC2025-02-20
2268721551912776K250015Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree AdhesiveDYH2025-01-03
2070051551912776K250015Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree AdhesiveDYH2025-01-03
2268721453048818K203737Spark Clear Aligner SystemNXC2021-03-22
2070051453048818K203737Spark Clear Aligner SystemNXC2021-03-22
2268721330944091K182826Ormco Spark Aligner SystemNXC2018-10-11
2070051330944091K182826Ormco Spark Aligner SystemNXC2018-10-11
2268721622023480K172845Symetri ClearNJM2018-01-31
2070051622023480K172845Symetri ClearNJM2018-01-31
2070051456964268K171844Inspire ICE aka Inspire ICE Clear BracketsNJM2017-07-18
2268721456964268K171844Inspire ICE aka Inspire ICE Clear BracketsNJM2017-07-18
2268721929762712K163317ELECTROmaticEBW2017-02-21
2268721674556296K141611LYTHOS DIGITAL IMPRESSION SYSTEMNOF2014-12-05
2070051674556296K141611LYTHOS DIGITAL IMPRESSION SYSTEMNOF2014-12-05
2268721060822142K123416INSIGNIA WITH ITERODYW2013-03-13
2070051060822142K123416INSIGNIA WITH ITERODYW2013-03-13
2268721798812687K123118INSIGNIA DIGICASTDYW2013-03-26
2070051798812687K123118INSIGNIA DIGICASTDYW2013-03-26
2268721395280209K122065DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USENOF2013-02-08
2070051395280209K122065DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USENOF2013-02-08
2070051247132746K121524INSIGNIADYW2012-08-09
2268721247132746K121524INSIGNIADYW2012-08-09
2268721285481513K081415DAMON 4CLEARNJM2008-09-24
2070051285481513K081415DAMON 4CLEARNJM2008-09-24
2268721332137240K061481GRENGLOODYH2006-07-06
2070051332137240K061481GRENGLOODYH2006-07-06
2268721196640679K061230VECTORS TEMPORARY ANCHORAGE SYSTEMOAT2006-08-03
2070051196640679K061230VECTORS TEMPORARY ANCHORAGE SYSTEMOAT2006-08-03
2070052043016960K052477DAMON 3 MODIFIEDDYW2005-11-30
2268722043016960K052477DAMON 3 MODIFIEDDYW2005-11-30
2268721969939290K042422D3 CHROMADYH2004-11-15
2070051969939290K042422D3 CHROMADYH2004-11-15
2268721283189459K032407OPTIBAND LCDYH2003-10-06
2070051283189459K032407OPTIBAND LCDYH2003-10-06
2268722037629364K020502SOLO ORTHO 3DYH2002-05-01
2070052037629364K020502SOLO ORTHO 3DYH2002-05-01
2268721049915184K001881IMPROVED ENLIGHT LVDYH2000-08-22
2070051049915184K001881IMPROVED ENLIGHT LVDYH2000-08-22
2268721094649693
2268721137683035
2268721185010824
2268721747465547
2268721093710454
2070051093710454
2268721112708164
2070051112708164
2268721139120057
2070051139120057
2268721183124001
2070051183124001
2070051185010824
2070051203181891
2268721203181891
2070051215676021
2268721215676021
2268721234761895
2070051234761895
2268721257205741
2268721268085893
2070051268085893
2268721303563594
2070051303563594
2070051440748921
2268721440748921
2268721446787354
2070051446787354
2268721486609531
2070051486609531
2268721578779785
2070051578779785
2268721599150210
2268721643830726
2070051643830726
2268721684426780
2070051688011236
2268721688011236
2268721822647216
2268721830186708
2070051830186708
2070051838691786
2268721838691786
2070051943036931
2268721943036931
2268721950341580
2070051950341580
2070051999787477
2268721999787477
2268722037207313
2070052037207313

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DYH182025-01-03
DYW112013-03-26
DZB101998-03-11
NJM72018-01-31
NXC62025-02-20
NOF42014-12-05
OAT22006-08-03
EMA21990-04-16
KLE21984-10-25
EBW12017-02-21

PMN#

GUDID#

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