Skip to the page
Get started – free

Data / Medical devices / United States / Ormco Corporation

Ormco Corporation: FDA-registered device maker in Brea, CA, United States, 31 510(k) clearances

Ormco Corporation is registered with the FDA (registration 3015272949) in Brea, CA, United States. It lists 37 device types. The FDA files 31 510(k) clearances under its listings, the newest dated February 20, 2025. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Ormco Corporation
FDA registration number
3015272949
Address
200 S. Kraemer Blvd --, Brea, CA, United States, 92821
Owner or operator
SYBRON DENTAL SPECIALTIES, INC. (9029565)
Roles
Complaint file establishment, Manufacturer, Specification developer
First device listed
December 15, 1977
Registered through
2027
Brand names listed
Adapt Luciwedge, Autofit Backfill Gutta Percha, Autofit Gutta Percha, Autofit Paper Points, Bite Wafer, Blue Cervical Foils, Blue Cervical Matrices, Blue Transparent Molar & Premolar Bands and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Implant, Dental, EndosseousNDP1Complaint file establishment, Specification developeraccessdata.fda.gov
Adhesive, Bracket And Tooth Conditioner, ResinDYH2Complaint file establishment, Specification developeraccessdata.fda.gov
Agent, Tooth Bonding, ResinKLE2Complaint file establishment, Specification developeraccessdata.fda.gov
Aligner, Bracket, OrthodonticECQ1Complaint file establishment, Specification developeraccessdata.fda.gov
Aligner, SequentialNXC2Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Applicator, ResinKXR1Specification developeraccessdata.fda.gov
Band, Elastic, OrthodonticECI1Complaint file establishment, Specification developeraccessdata.fda.gov
Band, Preformed, OrthodonticECM1Complaint file establishment, Specification developeraccessdata.fda.gov
Bracket, Ceramic, OrthodonticNJM2Complaint file establishment, Specification developeraccessdata.fda.gov
Bracket, Metal, OrthodonticEJF1Complaint file establishment, Specification developeraccessdata.fda.gov
Bracket, Plastic, OrthodonticDYW2Complaint file establishment, Specification developeraccessdata.fda.gov
Cement, DentalEMA2Complaint file establishment, Specification developeraccessdata.fda.gov
Clamp, Wire, OrthodonticECN1Complaint file establishment, Specification developeraccessdata.fda.gov
Controller, Foot, Handpiece And CordEBW1Complaint file establishmentaccessdata.fda.gov
ForcepsHTD1Complaint file establishment, Specification developeraccessdata.fda.gov
Gauge, Depth, Instrument, DentalEIL1Complaint file establishment, Specification developeraccessdata.fda.gov
Gutta-PerchaEKM1Specification developeraccessdata.fda.gov
Headgear, Extraoral, OrthodonticDZB2Complaint file establishment, Specification developeraccessdata.fda.gov
Implant, Endosseous, OrthodonticOAT2Complaint file establishment, Manufactureraccessdata.fda.gov
Indirect Bonding TrayQJJ1Complaint file establishment, Specification developeraccessdata.fda.gov
Instrument, Cutting, OperativeEKD1Complaint file establishment, Specification developeraccessdata.fda.gov
Instrument, Ligature Tucking, OrthodonticECP1Complaint file establishment, Specification developeraccessdata.fda.gov
Instruments, Dental HandDZN1Complaint file establishment, Specification developeraccessdata.fda.gov
Maintainer, Space Preformed, OrthodonticDYT1Complaint file establishment, Specification developeraccessdata.fda.gov
Mirror, MouthEAX1Complaint file establishment, Specification developeraccessdata.fda.gov
Orthodontic SoftwarePNN2Complaint file establishment, Specification developeraccessdata.fda.gov
Plier, OrthodonticJEX1Complaint file establishment, Specification developeraccessdata.fda.gov
Point, Paper, EndodonticEKN1Specification developeraccessdata.fda.gov
Pusher, Band, OrthodonticECS1Complaint file establishment, Specification developeraccessdata.fda.gov
Remover, CrownEIS1Complaint file establishment, Specification developeraccessdata.fda.gov
Setter, Band, OrthodonticECR1Complaint file establishment, Specification developeraccessdata.fda.gov
Spring, OrthodonticECO1Complaint file establishment, Specification developeraccessdata.fda.gov
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental RestorationsNOF2Complaint file establishment, Specification developeraccessdata.fda.gov
Tray, Impression, PreformedEHY1Complaint file establishment, Specification developeraccessdata.fda.gov
Tube, OrthodonticDZD1Complaint file establishment, Specification developeraccessdata.fda.gov
Wax, Dental, IntraoralEGD1Complaint file establishment, Specification developeraccessdata.fda.gov
Wire, OrthodonticDZC1Complaint file establishment, Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
February 20, 2025K250487SparkTM Clear Aligner SystemNXCSubstantially EquivalentOrmco Corporationaccessdata.fda.gov
January 3, 2025K250015Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree AdhesiveDYHSubstantially EquivalentOrmco Corporationaccessdata.fda.gov
March 22, 2021K203737Spark Clear Aligner SystemNXCSubstantially EquivalentOrmco Corporationaccessdata.fda.gov
October 11, 2018K182826Ormco Spark Aligner SystemNXCSubstantially EquivalentSybron Dental Specialtiesaccessdata.fda.gov
January 31, 2018K172845Symetri ClearNJMSubstantially EquivalentOrmco Corporationaccessdata.fda.gov
July 18, 2017K171844Inspire ICE aka Inspire ICE Clear BracketsNJMSubstantially EquivalentOrmco Corporationaccessdata.fda.gov
February 21, 2017K163317ELECTROmaticEBWSubstantially EquivalentKaltenbach & Voigt Gmghaccessdata.fda.gov
December 5, 2014K141611LYTHOS DIGITAL IMPRESSION SYSTEMNOFSubstantially EquivalentOrmco Corp.accessdata.fda.gov
March 26, 2013K123118INSIGNIA DIGICASTDYWSubstantially EquivalentOrmco Corp.accessdata.fda.gov
March 13, 2013K123416INSIGNIA WITH ITERODYWSubstantially EquivalentOrmco Corp.accessdata.fda.gov
February 8, 2013K122065DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USENOFSubstantially EquivalentOrmco Corp.accessdata.fda.gov
August 9, 2012K121524INSIGNIADYWSubstantially EquivalentOrmco Corp.accessdata.fda.gov
September 24, 2008K081415DAMON 4CLEARNJMSubstantially EquivalentOrmco Corp.accessdata.fda.gov
August 3, 2006K061230VECTORS TEMPORARY ANCHORAGE SYSTEMOATSubstantially EquivalentSybron Dental Specialtiesaccessdata.fda.gov
July 6, 2006K061481GRENGLOODYHSubstantially EquivalentOrmco Corp.accessdata.fda.gov
November 30, 2005K052477DAMON 3 MODIFIEDDYWSubstantially EquivalentOrmco Corp.accessdata.fda.gov
November 15, 2004K042422D3 CHROMADYHSubstantially EquivalentSybron Dental Specialties, Inc.accessdata.fda.gov
October 6, 2003K032407OPTIBAND LCDYHSubstantially EquivalentSybron Dental Specialties, Inc.accessdata.fda.gov
May 1, 2002K020502SOLO ORTHO 3DYHSubstantially EquivalentSybron Dental Specialties, Inc.accessdata.fda.gov
August 22, 2000K001881IMPROVED ENLIGHT LVDYHSubstantially EquivalentSybron Dental Specialties, Inc.accessdata.fda.gov
January 20, 1999K984217ENLIGHT-2DYHSubstantially EquivalentSybron Dental Specialties, Inc.accessdata.fda.gov
March 11, 1998K980195FACEBOWDZBSubstantially EquivalentOrtho Kinetics Corp.accessdata.fda.gov
August 23, 1994K943245SPIRIT MBDYWSubstantially EquivalentSybron Dental Specialties, Inc.accessdata.fda.gov
March 31, 1994K941015ORMCO SYSTEM 1+ (TM)DYHSubstantially EquivalentOrmco Corp.accessdata.fda.gov
December 4, 1992K923556ADP FACEMASKDZBSubstantially EquivalentOrmco Corp.accessdata.fda.gov
September 6, 1990K902646HOOD GEAR (TM) BREAKAWAY HEADGEAR WITH NECK STRAPDZBSubstantially EquivalentOrmco Corp.accessdata.fda.gov
September 6, 1990K902645HOOD GEAR (TM) BREAKAWAY HEADGEAR W/ HIGH PULLDZBSubstantially EquivalentOrmco Corp.accessdata.fda.gov
April 16, 1990K895386GLASIONEMASubstantially EquivalentScientific Pharmaceuticals, Inc.accessdata.fda.gov
May 18, 1987K871591ORMCO GEL-ETCHDYHSubstantially EquivalentScientific Pharmaceuticals, Inc.accessdata.fda.gov
July 11, 1986K862538SENTRY BREAKWAY NECK STRAPDZBSubstantially EquivalentOrmco Corp.accessdata.fda.gov
October 25, 1984K843023KERR PORCELAIN REPAIR PRIMERKLESubstantially EquivalentKerr Corporation (Danbury)accessdata.fda.gov

Compare with other makers

Updated February 20, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.