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Data / Medical devices / United States / First Dental Supplies LLC

First Dental Supplies LLC: FDA-registered device maker in Winter Garden, FL, United States, 4 510(k) clearances

First Dental Supplies LLC is registered with the FDA (registration 3022296393) in Winter Garden, FL, United States. It lists 30 device types. The FDA files 4 510(k) clearances under its listings, the newest dated August 14, 2020. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch First Dental Supplies LLC
FDA registration number
3022296393
Address
17808 Sharp Pummelo Aly, Winter Garden, FL, United States, 34787
Owner or operator
First Dental Supplies LLC (10084802)
Roles
Repackager or relabeler
First device listed
April 1, 2022
Registered through
2026
Brand names listed
ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN, Aligner, Bracket, Orthodontic, BAR, PREFORMED, BRACKET, CERAMIC, ORTHODONTIC, BUR, DENTAL, Band, Elastic, Orthodontic, Bracket, Metal, Orthodontic, Clamp, Wire, Orthodontic and more

Devices it lists

DeviceProduct codeClassRoleSource
Adhesive, Bracket And Tooth Conditioner, ResinDYH2Repackager or relabeleraccessdata.fda.gov
Aligner, Bracket, OrthodonticECQ1Repackager or relabeleraccessdata.fda.gov
Band, Elastic, OrthodonticECI1Repackager or relabeleraccessdata.fda.gov
Band, Material, OrthodonticDYO1Repackager or relabeleraccessdata.fda.gov
Bar, PreformedEHO1Repackager or relabeleraccessdata.fda.gov
Bracket, Ceramic, OrthodonticNJM2Repackager or relabeleraccessdata.fda.gov
Bracket, Metal, OrthodonticEJF1Repackager or relabeleraccessdata.fda.gov
Bur, DentalEJL1Repackager or relabeleraccessdata.fda.gov
Cement, DentalEMA2Repackager or relabeleraccessdata.fda.gov
Clamp, Wire, OrthodonticECN1Repackager or relabeleraccessdata.fda.gov
FacebowKCR1Repackager or relabeleraccessdata.fda.gov
Implant, Endosseous, OrthodonticOAT2Repackager or relabeleraccessdata.fda.gov
Instrument, Ligature Tucking, OrthodonticECP1Repackager or relabeleraccessdata.fda.gov
Instruments, Dental HandDZN1Repackager or relabeleraccessdata.fda.gov
Material, Tooth Shade, ResinEBF2Repackager or relabeleraccessdata.fda.gov
Plier, OrthodonticJEX1Repackager or relabeleraccessdata.fda.gov
Point, AbrasiveEHL1Repackager or relabeleraccessdata.fda.gov
Positioner, Tooth, PreformedKMY1Repackager or relabeleraccessdata.fda.gov
Pusher, Band, OrthodonticECS1Repackager or relabeleraccessdata.fda.gov
Retainer, Screw Expansion, OrthodonticDYJ1Repackager or relabeleraccessdata.fda.gov
Retractor, All TypesEIG1Repackager or relabeleraccessdata.fda.gov
Scraper, TongueLCN1Repackager or relabeleraccessdata.fda.gov
Setter, Band, OrthodonticECR1Repackager or relabeleraccessdata.fda.gov
Spring, OrthodonticECO1Repackager or relabeleraccessdata.fda.gov
Strip, Polishing AgentEHM1Repackager or relabeleraccessdata.fda.gov
Toothbrush, ManualEFW1Repackager or relabeleraccessdata.fda.gov
Tray, Impression, PreformedEHY1Repackager or relabeleraccessdata.fda.gov
Tube, OrthodonticDZD1Repackager or relabeleraccessdata.fda.gov
Wax, Dental, IntraoralEGD1Repackager or relabeleraccessdata.fda.gov
Wire, OrthodonticDZC1Repackager 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
August 14, 2020K192682Orthocem, Ortho BiteDYHSubstantially EquivalentDentscare Ltdaaccessdata.fda.gov
November 2, 2019K183465Allcem, Allcem CoreEMASubstantially EquivalentDentscare Ltdaaccessdata.fda.gov
January 8, 2014K130476ORTHODONTIC MINISCREW FOR ABSOLUTE ANCHORAGEOATSubstantially EquivalentDental Morelliaccessdata.fda.gov
August 27, 2013K131197EDGEWISE CERAMIC BRACKETS, ROTH CERAMIC BRACKETSNJMSubstantially EquivalentDental Morelliaccessdata.fda.gov

Compare with other makers

Updated August 14, 2020. 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.