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Data / Medical devices / United States / Nusmile, Ltd

Nusmile, Ltd: FDA-registered device maker in Houston, TX, United States, 15 510(k) clearances

Nusmile, Ltd is registered with the FDA (registration 3006444232) in Houston, TX, United States. It lists 22 device types. The FDA files 15 510(k) clearances under its listings, the newest dated September 4, 2026. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Nusmile, Ltd
FDA registration number
3006444232
Address
3315 W 12th St, Houston, TX, United States, 77008
Owner or operator
NUSMILE, LTD (9106343)
Roles
Manufacturer, Repackager or relabeler, Specification developer
First device listed
August 27, 2007
Registered through
2026
Brand names listed
ApicalShaper File, ApicalShaper Gutta-Percha, ApicalShaper Paper Point, Avalon Biomed Basic Flex Tips, Avalon Biomed Clear Flex Tips, Avalon Biomed Grey MTA Plus, Avalon Biomed Navi TIps, Avalon Biomed NeoMTA 2 and more

Devices it lists

DeviceProduct codeClassRoleSource
Bur, Surgical, General & Plastic SurgeryGFF1Repackager or relabeleraccessdata.fda.gov
Cement, DentalEMA2Repackager or relabeler, Specification developeraccessdata.fda.gov
Cleanser, Root CanalKJJURepackager or relabeleraccessdata.fda.gov
Crown, PreformedELZ1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Cutter, WireHXZ1Repackager or relabeleraccessdata.fda.gov
Diammine Silver Fluoride Dental Hypersensitivity VarnishPHR2Repackager or relabeleraccessdata.fda.gov
File, Pulp Canal, EndodonticEKS1Repackager or relabeleraccessdata.fda.gov
Gauge, Depth, Instrument, DentalEIL1Repackager or relabeleraccessdata.fda.gov
Gutta-PerchaEKM1Repackager or relabeleraccessdata.fda.gov
Handpiece, Direct Drive, Ac-PoweredEKX1Repackager or relabeleraccessdata.fda.gov
Instruments, Dental HandDZN1Repackager or relabeleraccessdata.fda.gov
Liner, Cavity, Calcium HydroxideEJK2Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Locator, Root ApexLQYURepackager or relabeleraccessdata.fda.gov
Maintainer, Space Preformed, OrthodonticDYT1Repackager or relabeler, Specification developeraccessdata.fda.gov
Plier, OrthodonticJEX1Repackager or relabeleraccessdata.fda.gov
Plugger, Root Canal, EndodonticEKR1Repackager or relabeleraccessdata.fda.gov
Point, Paper, EndodonticEKN1Repackager or relabeleraccessdata.fda.gov
Resin, Root Canal FillingKIF2Manufactureraccessdata.fda.gov
Scissors, Surgical Tissue, DentalEGN1Repackager or relabeleraccessdata.fda.gov
Sealant, Pit And Fissure, And ConditionerEBC2Repackager or relabeleraccessdata.fda.gov
Syringe, Periodontic, Endodontic, IrrigatingEIC1Repackager or relabeleraccessdata.fda.gov
Varnish, CavityLBH2Repackager 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
September 4, 2026K253909NeoPEX™ Pre-Mixed Obturation PasteKIFSubstantially EquivalentNuSmile, Ltd.accessdata.fda.gov
June 20, 2025K250566EsCem RMGIEMASubstantially EquivalentSpident Co., Ltd.accessdata.fda.gov
August 27, 2024K241354Sealer SolventKJJSubstantially EquivalentInter-Med, Inc.accessdata.fda.gov
March 6, 2024K240619e-SDFPHRSubstantially EquivalentKids-E-Dental Llpaccessdata.fda.gov
October 27, 2023K222459Centrix FluoroSilver Silver Diamine Fluoride 38%PHRSubstantially EquivalentCentrix, Inc.accessdata.fda.gov
January 29, 2021K201993E-connect S Endo Motor with built-in Apex LocatorEKXSubstantially EquivalentChangzhou Sifary Medical Technology Co., Ltd.accessdata.fda.gov
November 20, 2020K202413LC ResinCal PCEJKSubstantially EquivalentS&C Polymer Silicon- Und Composite Spezialitaten GmbHaccessdata.fda.gov
January 11, 2019K181917MTA2.3 MATERIALSKIFSubstantially EquivalentNuSmile, Ltd.accessdata.fda.gov
September 1, 2016K161239MTA2.2 MATERIALKIFSubstantially EquivalentAvalon Biomed, Inc.accessdata.fda.gov
June 11, 2014K140955MTA2.1 MATERIALKIFSubstantially EquivalentAvalon Biomed, Inc.accessdata.fda.gov
November 1, 2013K132109ENAMELASTLBHSubstantially EquivalentUltradent Products Inc. / Oratech, LLCaccessdata.fda.gov
December 11, 2012K122892MTA2 ROOT AND PULP MATERIALSKIFSubstantially EquivalentAvalon Biomed, Inc.accessdata.fda.gov
December 7, 2012K123265RMGI LOW VISCOSITYEMASubstantially EquivalentPulpdent Corporationaccessdata.fda.gov
September 23, 2011K112517ULTRASEAL XT HYDROEBCSubstantially EquivalentUltradent Products, Inc.accessdata.fda.gov
February 4, 2004K040098VARNISHAMERICALBHSubstantially EquivalentMedical Products Laboratories, Inc.accessdata.fda.gov

Compare with other makers

Updated September 4, 2026. 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.