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Data / Medical devices / United States / Alta Smiles, LLC

Alta Smiles, LLC: FDA-registered device maker in Fort Washington, PA, United States, 1 510(k) clearance

Alta Smiles, LLC is registered with the FDA (registration 3017138012) in Fort Washington, PA, United States. It lists 19 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 2, 2021. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Alta Smiles, LLC
FDA registration number
3017138012
Address
1300 Virginia Drive Suite 119, Fort Washington, PA, United States, 19034
Owner or operator
Alta Smiles, Inc (10090088)
Roles
Manufacturer, Repackager or relabeler, Specification developer
First device listed
February 13, 2024
Registered through
2026
Brand names listed
Alta-Clear, Alta-Flex, Franks, Prowire, Retain, V5X

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Retractor, DentalEIF1Repackager or relabeleraccessdata.fda.gov
Aligner, SequentialNXC2Manufactureraccessdata.fda.gov
Band, Elastic, OrthodonticECI1Repackager or relabeleraccessdata.fda.gov
Bracket, Metal, OrthodonticEJF1Repackager or relabeleraccessdata.fda.gov
Gauge, Depth, Instrument, DentalEIL1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Indirect Bonding TrayQJJ1Manufactureraccessdata.fda.gov
Instrument, Cutting, OperativeEKD1Repackager or relabeleraccessdata.fda.gov
Instrument, Diamond, DentalDZP1Repackager or relabeleraccessdata.fda.gov
Instrument, Filling, Plastic, DentalEIY1Repackager or relabeleraccessdata.fda.gov
Instrument, Ligature Tucking, OrthodonticECP1Repackager or relabeleraccessdata.fda.gov
Instruments, Dental HandDZN1Repackager or relabeleraccessdata.fda.gov
Plier, OrthodonticJEX1Repackager or relabeleraccessdata.fda.gov
Positioner, Tooth, PreformedKMY1Repackager or relabeler, Specification developeraccessdata.fda.gov
Retainer, Screw Expansion, OrthodonticDYJ1Repackager or relabeler, Specification developeraccessdata.fda.gov
Retractor, All TypesEIG1Repackager or relabeler, Specification developeraccessdata.fda.gov
Spring, OrthodonticECO1Repackager or relabeleraccessdata.fda.gov
Tube, OrthodonticDZD1Repackager or relabeleraccessdata.fda.gov
Wax, Dental, IntraoralEGD1Repackager or relabeleraccessdata.fda.gov
Wire, OrthodonticDZC1Manufacturer, Repackager 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
June 2, 2021K2106526MS Invisible AlignerNXCSubstantially EquivalentSms Opco, LLCaccessdata.fda.gov

Compare with other makers

Updated June 2, 2021. 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.