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Data / Medical devices / United States / Atomo Dental, Inc.

Atomo Dental, Inc.: FDA-registered device maker in Pleasanton, CA, United States, 4 510(k) clearances

Atomo Dental, Inc. is registered with the FDA (registration 3011279497) in Pleasanton, CA, United States. It lists 30 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 25, 2013. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Atomo Dental, Inc.
FDA registration number
3011279497
Address
1241 Quarry Lane, Suite 125, Pleasanton, CA, United States, 94566
Owner or operator
ATOMO Dental, Inc. (10047993)
Roles
Repackager or relabeler
First device listed
November 22, 2014
Registered through
2026
Brand names listed
ATOMO air compressor and vacuum unit, ATOMO dental chair, Barrier Film; Handpiece Sleeves; Instrument Tray Sleeves; Light/Sensor Sleeves/Pouches; Barrier Sleeves; Syringe Sleeves, Bouffant Cap, Cotton Roll, Coverall Surgical Suit, Dental Impression Tray, Bite Registration Tray, Disposable Impression Tray, Dental Loupes and more

Devices it lists

DeviceProduct codeClassRoleSource
Absorber, Saliva, PaperKHR1Repackager or relabeleraccessdata.fda.gov
Accessory, Surgical ApparelLYU1Repackager or relabeleraccessdata.fda.gov
Applicator, ResinKXR1Repackager or relabeleraccessdata.fda.gov
Camera, Television, Endoscopic, Without AudioFWF1Repackager or relabeleraccessdata.fda.gov
Cap, SurgicalFYF1Repackager or relabeleraccessdata.fda.gov
Carver, Dental Amalgam, OperativeEKH1Repackager or relabeleraccessdata.fda.gov
Chair, Dental, Without Operative UnitNRU1Repackager or relabeleraccessdata.fda.gov
Cleaner, Ultrasonic, Medical InstrumentFLG1Repackager or relabeleraccessdata.fda.gov
Cotton, RollEFN1Repackager or relabeleraccessdata.fda.gov
Cup, ProphylaxisEHK1Repackager or relabeleraccessdata.fda.gov
Disinfectant, Medical DevicesLRJ1Repackager or relabeleraccessdata.fda.gov
Dispenser, Liquid MedicationKYX1Repackager or relabeleraccessdata.fda.gov
Floss, DentalJES1Repackager or relabeleraccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Repackager or relabeleraccessdata.fda.gov
Handpiece, Contra- And Right-Angle Attachment, DentalEGS1Repackager or relabeleraccessdata.fda.gov
Heat Source For Bleaching TeethEEG1Repackager or relabeleraccessdata.fda.gov
Instrument, Filling, Plastic, DentalEIY1Repackager or relabeleraccessdata.fda.gov
Loupe, Diagnostic/SurgicalFSP1Repackager or relabeleraccessdata.fda.gov
Mask, ScavengingKHA1Repackager or relabeleraccessdata.fda.gov
Mouthpiece, Saliva EjectorDYN1Repackager or relabeleraccessdata.fda.gov
Non-Surgical GownOEA1Repackager or relabeleraccessdata.fda.gov
Polymer Patient Examination GloveLZA1Repackager or relabeleraccessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY1Repackager or relabeleraccessdata.fda.gov
Suit, SurgicalFXO1Repackager or relabeleraccessdata.fda.gov
Syringe, Restorative And Impression MaterialEID1Repackager or relabeleraccessdata.fda.gov
Toothbrush, ManualEFW1Repackager or relabeleraccessdata.fda.gov
Tray, Impression, PreformedEHY1Repackager or relabeleraccessdata.fda.gov
Unit, Operative Dental, AccessoriesNRD1Repackager or relabeleraccessdata.fda.gov
Unit, Syringe, Air And/Or WaterECB1Repackager 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
September 25, 2013K131440POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUELZASubstantially EquivalentHebei Hongsen Plastics Technology Co, Ltd.accessdata.fda.gov
July 19, 2012K120970NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, COLORED (BLUE)LZASubstantially EquivalentTangshan Zhonghong Pulin Plastic Co.,Ltdaccessdata.fda.gov
December 9, 2010K100854PREMIUM PLUS DISPOSABLE PROPHY ANGLE MODEL 3399EGSSubstantially EquivalentPremium Plus International Limitedaccessdata.fda.gov
December 27, 2007K071886SELF SEAL STERILIZATION POUCHFRGSubstantially EquivalentShanghai Jianzhong Medical Packaging Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated September 25, 2013. 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.