Skip to the page
Get started free

Data / Medical devices / United States / White Oak Orthodontic Products

White Oak Orthodontic Products: FDA-registered device maker in Mount Joy, PA, United States, 2 510(k) clearances

White Oak Orthodontic Products is registered with the FDA (registration 3009827000) in Mount Joy, PA, United States. It lists 22 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 11, 1998. 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 White Oak Orthodontic Products
FDA registration number
3009827000
Address
330 E Main St, Mount Joy, PA, United States, 17552
Owner or operator
White Oak Orthodontic Products (10042063)
Roles
Repackager or relabeler
First device listed
October 15, 2012
Registered through
2027
Brand names listed
Ghost, Halo, Infinity, Innova, Integrity, Lux V-Slot, MACHI, MACHII and more

Devices it lists

DeviceProduct codeClassRoleSource
Aligner, Bracket, OrthodonticECQ1Repackager or relabeleraccessdata.fda.gov
Band, Elastic, OrthodonticECI1Repackager or relabeleraccessdata.fda.gov
Band, Preformed, OrthodonticECM1Repackager or relabeleraccessdata.fda.gov
Bracket, Metal, OrthodonticEJF1Repackager or relabeleraccessdata.fda.gov
Clamp, Wire, OrthodonticECN1Repackager or relabeleraccessdata.fda.gov
Driver, Band, OrthodonticECT1Repackager or relabeleraccessdata.fda.gov
Floss, DentalJES1Repackager or relabeleraccessdata.fda.gov
Headgear, Extraoral, OrthodonticDZB2Repackager or relabeleraccessdata.fda.gov
Instrument, Ligature Tucking, OrthodonticECP1Repackager or relabeleraccessdata.fda.gov
Instruments, Dental HandDZN1Repackager or relabeleraccessdata.fda.gov
Mirror, MouthEAX1Repackager or relabeleraccessdata.fda.gov
Plier, OrthodonticJEX1Repackager or relabeleraccessdata.fda.gov
Protector, DentalBRW1Repackager or relabeleraccessdata.fda.gov
ProtractorHTH1Repackager or relabeleraccessdata.fda.gov
Pusher, Band, OrthodonticECS1Repackager or relabeleraccessdata.fda.gov
Setter, Band, OrthodonticECR1Repackager or relabeleraccessdata.fda.gov
Spring, OrthodonticECO1Repackager or relabeleraccessdata.fda.gov
TemplateHWT1Repackager or relabeleraccessdata.fda.gov
Toothbrush, ManualEFW1Repackager or relabeleraccessdata.fda.gov
Tray, Impression, PreformedEHY1Repackager or relabeleraccessdata.fda.gov
Tube, OrthodonticDZD1Repackager 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
March 11, 1998K980195FACEBOWDZBSubstantially EquivalentOrtho Kinetics Corp.accessdata.fda.gov
July 30, 1992K922499REFLECTIONS - CERAMIC DENTAL BRACKETEJFSubstantially EquivalentCdb Corp.accessdata.fda.gov

Compare with other makers

Updated March 11, 1998. 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.