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Data / Medical devices / United States / Nucare LLC

Nucare LLC: FDA-registered device maker in Montclair, CA, United States, 4 510(k) clearances

Nucare LLC is registered with the FDA (registration 3042367543) in Montclair, CA, United States. It lists 24 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 10, 2019. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Nucare LLC
FDA registration number
3042367543
Address
10680 Silicon Ave Unit A (Unit 20, Montclair, CA, United States, 91763
Owner or operator
NuCare LLC (10094265)
Roles
Complaint file establishment, Specification developer
First device listed
November 29, 2025
Registered through
2026
Brand names listed
Air Water Syringe Tip, Barrier Film, Bib Holder, Bite Registration Trays, Cartridge Gun, Cotton Tipped Applicators, Crepe Paper Rolls, Dental Rolls and more

Devices it lists

DeviceProduct codeClassRoleSource
Absorber, Saliva, PaperKHR1Specification developeraccessdata.fda.gov
Accessories, Retractor, DentalEIF1Specification developeraccessdata.fda.gov
Accessory, Surgical ApparelLYU1Specification developeraccessdata.fda.gov
Applicator, Absorbent Tipped, Non-SterileKXF1Complaint file establishment, Specification developeraccessdata.fda.gov
Bedding, Disposable, MedicalKME1Specification developeraccessdata.fda.gov
Chair, Dental, Without Operative UnitNRU1Specification developeraccessdata.fda.gov
Container, Specimen, Non-SterileNNI1Specification developeraccessdata.fda.gov
Cotton, RollEFN1Complaint file establishment, Specification developeraccessdata.fda.gov
Dental Barriers And SleevesPEM2Specification developeraccessdata.fda.gov
Finger CotLZB1Specification developeraccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Specification developeraccessdata.fda.gov
Gown, ExaminationFME1Specification developeraccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Specification developeraccessdata.fda.gov
Handle, Instrument, DentalEJB1Specification developeraccessdata.fda.gov
Latex Patient Examination GloveLYY1Specification developeraccessdata.fda.gov
Mask, SurgicalFXX2Specification developeraccessdata.fda.gov
Material, Impression Tray, ResinEBH1Specification developeraccessdata.fda.gov
Mirror, MouthEAX1Specification developeraccessdata.fda.gov
Mouthpiece, Saliva EjectorDYN1Specification developeraccessdata.fda.gov
Retractor, All TypesEIG1Specification developeraccessdata.fda.gov
Syringe, Irrigating (Non Dental)KYZ1Specification developeraccessdata.fda.gov
Unit, Operative Dental, AccessoriesNRD1Specification developeraccessdata.fda.gov
Unit, Syringe, Air And/Or WaterECB1Specification developeraccessdata.fda.gov
Wrap, SterilizationFRG2Specification developeraccessdata.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 10, 2019K190484BH Medical Dental Barrier Sleeves and Barrier FilmPEMSubstantially EquivalentBh Medical Products Co., Ltd.accessdata.fda.gov
August 3, 2018K172280BH Sterilization PouchFRGSubstantially EquivalentBh Medical Products Co., Ltd.accessdata.fda.gov
June 22, 2015K133070SURGICAL FACE MASK (Ear Loops and Tie-on)FXXSubstantially EquivalentBh Medical Products Co., Ltd.accessdata.fda.gov
June 9, 1998K980494SUPERGLOVESLYYSubstantially EquivalentSupermax Sdn Bhdaccessdata.fda.gov

Compare with other makers

Updated September 10, 2019. 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.