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Data / Medical devices / United States / Ortho Arch Company Inc

Ortho Arch Company Inc: FDA-registered device maker in Schaumburg, IL, United States, 3 510(k) clearances

Ortho Arch Company Inc is registered with the FDA (registration 3007284437) in Schaumburg, IL, United States. It lists 28 device types. The FDA files 3 510(k) clearances under its listings, the newest dated May 15, 2015. Registered through 2026. FDA data exported November 3, 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 Ortho Arch Company Inc
FDA registration number
3007284437
Address
1107 Tower Road, Schaumburg, IL, United States, 60173
Owner or operator
ORTHO ARCH COMPANY INC (10030081)
Roles
Repackager or relabeler
First device listed
August 10, 2009
Registered through
2026
Brand names listed
AJ Wilcock Australian Wire 25" Spool and 14" Length Wire, Aligner Scissors, Amber Interoral Elastics, Rainbow Interoral Elastics, Non-Latex Clear Interoral Elastics, Arch Markers, Beta Titanium, Black Satin SE Niti, Brehm Niti Utility Arch, Buccal Tubes and more

Devices it lists

DeviceProduct codeClassRoleSource
Activator, Ultraviolet, For PolymerizationEBZ2Repackager or relabeleraccessdata.fda.gov
Aligner, Bracket, OrthodonticECQ1Repackager or relabeleraccessdata.fda.gov
Applicator, ResinKXR1Repackager or relabeleraccessdata.fda.gov
Band, Elastic, OrthodonticECI1Repackager or relabeleraccessdata.fda.gov
Bracket, Ceramic, OrthodonticNJM2Repackager or relabeleraccessdata.fda.gov
Bracket, Metal, OrthodonticEJF1Repackager or relabeleraccessdata.fda.gov
Bracket, Plastic, OrthodonticDYW2Repackager or relabeleraccessdata.fda.gov
Clamp, Wire, OrthodonticECN1Repackager or relabeleraccessdata.fda.gov
Cutter, WireHXZ1Repackager or relabeleraccessdata.fda.gov
File, Pulp Canal, EndodonticEKS1Repackager or relabeleraccessdata.fda.gov
Floss, DentalJES1Repackager or relabeleraccessdata.fda.gov
Forceps, Tooth Extractor, SurgicalEMG1Repackager or relabeleraccessdata.fda.gov
Gauge, Depth, Instrument, DentalEIL1Repackager or relabeleraccessdata.fda.gov
Instrument, Ligature Tucking, OrthodonticECP1Repackager or relabeleraccessdata.fda.gov
Instruments, Dental HandDZN1Repackager or relabeleraccessdata.fda.gov
Marker, PeriodonticEMP1Repackager or relabeleraccessdata.fda.gov
Mirror, MouthEAX1Repackager or relabeleraccessdata.fda.gov
Mouthpiece, Saliva EjectorDYN1Repackager or relabeleraccessdata.fda.gov
Patient Personal Hygiene KitNSB1Repackager or relabeleraccessdata.fda.gov
Plier, OrthodonticJEX1Repackager or relabeleraccessdata.fda.gov
Positioner, Tooth, PreformedKMY1Repackager or relabeleraccessdata.fda.gov
Retractor, All TypesEIG1Repackager or relabeleraccessdata.fda.gov
Scissors, Surgical Tissue, DentalEGN1Repackager or relabeleraccessdata.fda.gov
Spring, OrthodonticECO1Repackager or relabeleraccessdata.fda.gov
Toothbrush, ManualEFW1Repackager or relabeleraccessdata.fda.gov
Tube, OrthodonticDZD1Repackager or relabeleraccessdata.fda.gov
Wax, Dental, IntraoralEGD1Repackager or relabeleraccessdata.fda.gov
Wire, OrthodonticDZC1Repackager or relabeleraccessdata.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
May 15, 2015K142729Chi Lites Orthodontic Sapphire BracketNJMSubstantially EquivalentProgressive Technology, Inc.accessdata.fda.gov
September 28, 2005K052593FUSION CURING LIGHTEBZSubstantially EquivalentDentlight, Inc.accessdata.fda.gov
November 21, 1997K973776REFLECTIONSDYWSubstantially EquivalentCdb Corp.accessdata.fda.gov

Compare with other makers

Updated May 15, 2015. 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.