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Data / Medical devices / United States / Dentsply Sirona Orthodontics Inc.

Dentsply Sirona Orthodontics Inc.: FDA-registered device maker in Sarasota, FL, United States, 1 510(k) clearance

Dentsply Sirona Orthodontics Inc. is registered with the FDA (registration 1036212) in Sarasota, FL, United States. It lists 19 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 27, 2006. Registered through 2026. 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 Dentsply Sirona Orthodontics Inc.
FDA registration number
1036212
Address
7290 26th Court East, Sarasota, FL, United States, 34243
Owner or operator
DENTSPLY SIRONA INC (2511302)
Roles
Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
First device listed
February 20, 1979
Registered through
2026
Brand names listed
Adhesive Bite-Wing Tabs, Adhesive Comfort Tab for Film -Cover Cozee®, Aquasil Ultra Cordless digit Power Dispenser, BAI Bite-Block film holders, BAI Instrument Kits, Bite-Wing Bite-Blocks film holders, Bite-Wing Instrument Kits, Bite-Wing Loops film holders and more

Devices it lists

DeviceProduct codeClassRoleSource
Aligner, Beam, X-RayEHA1Contract manufactureraccessdata.fda.gov
Aligner, SequentialNXC2Manufacturer, Specification developeraccessdata.fda.gov
Cleaner, Denture, MechanicalJER1Repackager or relabeleraccessdata.fda.gov
Cleanser, Denture, Over The CounterEFT1Repackager or relabeler, Specification developeraccessdata.fda.gov
Crown And Bridge, Temporary, ResinEBG2Manufacturer, Specification developeraccessdata.fda.gov
Dental Prophylaxis KitNYC1Specification developeraccessdata.fda.gov
Evacuator, Oral CavityEHZ1Contract manufactureraccessdata.fda.gov
Holder, Film, X-RayEGZ1Contract manufactureraccessdata.fda.gov
Indirect Bonding TrayQJJ1Contract manufactureraccessdata.fda.gov
Instrument, Filling, Plastic, DentalEIY1Manufactureraccessdata.fda.gov
Instruments, Dental HandDZN1Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Mouthguard, PrescriptionMQCUManufacturer, Specification developeraccessdata.fda.gov
Positioner, Tooth, PreformedKMY1Manufacturer, Specification developeraccessdata.fda.gov
Pusher, Band, OrthodonticECS1Manufactureraccessdata.fda.gov
Setter, Band, OrthodonticECR1Manufactureraccessdata.fda.gov
Strip, Polishing AgentEHM1Manufacturer, Repackager or relabeleraccessdata.fda.gov
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental RestorationsNOF2Contract manufactureraccessdata.fda.gov
Unit, Syringe, Air And/Or WaterECB1Contract manufactureraccessdata.fda.gov
Wire, OrthodonticDZC1Contract manufactureraccessdata.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
November 27, 2006K062828MOUTHGUARD AND ALIGNER MATERIALSMQCSubstantially EquivalentDentsply Intl., Inc.accessdata.fda.gov

Compare with other makers

Updated November 27, 2006. 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.