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Data / Medical devices / United States / Midwest Dental

Midwest Dental: FDA-registered device maker in Wichita Falls, TX, United States, 3 510(k) clearances

Midwest Dental is registered with the FDA (registration 3004201548) in Wichita Falls, TX, United States. It lists 25 device types. The FDA files 3 510(k) clearances under its listings, the newest dated May 4, 2023. 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 Midwest Dental
FDA registration number
3004201548
Address
2700 Commerce St, Wichita Falls, TX, United States, 76301
Owner or operator
Midwest Dental (10089806)
Roles
Repackager or relabeler
First device listed
June 17, 2024
Registered through
2026
Brand names listed
Advance Copper NiTi Archwire, Advance Elastic Chain, 15ft, Advance Elastic Chain, 5ft, Advance Elastic Separators, Advance NiTi Super-Elastic Reverse Curve Archwire, Advance Ortho Instruments, Advance Precision Premium Bonding Tubes, Advance Precision Premium Series Brackets and more

Devices it lists

DeviceProduct codeClassRoleSource
Absorber, Saliva, PaperKHR1Repackager or relabeleraccessdata.fda.gov
Adaptor, HygieneILS1Repackager or relabeleraccessdata.fda.gov
Applicator, Absorbent Tipped, Non-SterileKXF1Repackager or relabeleraccessdata.fda.gov
Band, Elastic, OrthodonticECI1Repackager or relabeleraccessdata.fda.gov
Barrier, Control Panel, X-Ray, MovableIWX1Repackager or relabeleraccessdata.fda.gov
Bracket, Ceramic, OrthodonticNJM2Repackager or relabeleraccessdata.fda.gov
Bracket, Metal, OrthodonticEJF1Repackager or relabeleraccessdata.fda.gov
Dispenser, Liquid MedicationKYX1Repackager or relabeleraccessdata.fda.gov
Evacuator, Oral CavityEHZ1Repackager or relabeleraccessdata.fda.gov
Indicator, Physical/Chemical Sterilization ProcessJOJ2Repackager or relabeleraccessdata.fda.gov
Instruments, Dental HandDZN1Repackager or relabeleraccessdata.fda.gov
Mask, SurgicalFXX2Repackager or relabeleraccessdata.fda.gov
Mixer, Cement, For Clinical UseJDZ1Repackager or relabeleraccessdata.fda.gov
Mouthpiece, Saliva EjectorDYN1Repackager or relabeleraccessdata.fda.gov
Needle, DentalDZM1Repackager or relabeleraccessdata.fda.gov
Non-Surgical GownOEA1Repackager or relabeleraccessdata.fda.gov
Retainer, Screw Expansion, OrthodonticDYJ1Repackager or relabeleraccessdata.fda.gov
Spring, OrthodonticECO1Repackager or relabeleraccessdata.fda.gov
Syringe, Periodontic, Endodontic, IrrigatingEIC1Repackager or relabeleraccessdata.fda.gov
Toothbrush, PoweredJEQ1Repackager or relabeleraccessdata.fda.gov
Tube, OrthodonticDZD1Repackager or relabeleraccessdata.fda.gov
Unit, Operative Dental, AccessoriesNRD1Repackager or relabeleraccessdata.fda.gov
Unit, Syringe, Air And/Or WaterECB1Repackager or relabeleraccessdata.fda.gov
Wire, OrthodonticDZC1Repackager or relabeleraccessdata.fda.gov
Wrap, SterilizationFRG2Repackager 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 4, 2023K222847Ceramic Brackets OrthometricNJMSubstantially EquivalentOrthometric - Industria E Comercio DE Produtos Medicosaccessdata.fda.gov
February 13, 2023K221875Sterilization Pouch and RollFRGSubstantially EquivalentQianjiang Kingphar Medical Packaging & Printing Co., Ltd.accessdata.fda.gov
June 6, 2022K221222Surgical Face Mask (HNFM0304)FXXSubstantially EquivalentShanghai Hua EN Industrial Co, Ltd.accessdata.fda.gov

Compare with other makers

Updated May 4, 2023. 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.