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Data / Medical devices / United States / Csy International LLC

Csy International LLC: FDA-registered device maker in Rancho Cucamonga, CA, United States, 8 510(k) clearances

Csy International LLC is registered with the FDA (registration 3016543896) in Rancho Cucamonga, CA, United States. It lists 27 device types. The FDA files 8 510(k) clearances under its listings, the newest dated March 12, 2021. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Csy International LLC
FDA registration number
3016543896
Address
6737 Palo Verde Pl, Rancho Cucamonga, CA, United States, 91739
Owner or operator
CSY INTERNATIONAL LLC (10062340)
Roles
Repackager or relabeler
First device listed
January 14, 2020
Registered through
2027
Brand names listed
Beacon, CICADA, Caber, Claro, Dorada, GNI, J&J ORTHODONTICS, J&J Ortho and more

Devices it lists

DeviceProduct codeClassRoleSource
Activator, Ultraviolet, For PolymerizationEBZ2Repackager or relabeleraccessdata.fda.gov
Adhesive, Bracket And Tooth Conditioner, ResinDYH2Repackager or relabeleraccessdata.fda.gov
Agent, Polishing, Abrasive, Oral CavityEJR1Repackager or relabeleraccessdata.fda.gov
Aligner, Bracket, OrthodonticECQ1Repackager or relabeleraccessdata.fda.gov
Applicator, ResinKXR1Repackager or relabeleraccessdata.fda.gov
Band, Elastic, OrthodonticECI1Repackager or relabeleraccessdata.fda.gov
Band, Material, OrthodonticDYO1Repackager or relabeleraccessdata.fda.gov
Band, Preformed, OrthodonticECM1Repackager or relabeleraccessdata.fda.gov
Bracket, Ceramic, OrthodonticNJM2Repackager or relabeleraccessdata.fda.gov
Bracket, Metal, OrthodonticEJF1Repackager or relabeleraccessdata.fda.gov
Clamp, Wire, OrthodonticECN1Repackager or relabeleraccessdata.fda.gov
Driver, Band, OrthodonticECT1Repackager or relabeleraccessdata.fda.gov
Headgear, Extraoral, OrthodonticDZB2Repackager or relabeleraccessdata.fda.gov
Implant, Endosseous, OrthodonticOAT2Repackager or relabeleraccessdata.fda.gov
Instrument, Ligature Tucking, OrthodonticECP1Repackager or relabeleraccessdata.fda.gov
Maintainer, Space Preformed, OrthodonticDYT1Repackager or relabeleraccessdata.fda.gov
Mirror, MouthEAX1Repackager or relabeleraccessdata.fda.gov
Plier, OrthodonticJEX1Repackager 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
Setter, Band, OrthodonticECR1Repackager or relabeleraccessdata.fda.gov
Spring, OrthodonticECO1Repackager or relabeleraccessdata.fda.gov
Stripper, SurgicalHRT1Repackager or relabeleraccessdata.fda.gov
Tray, Impression, PreformedEHY1Repackager or relabeleraccessdata.fda.gov
Tube, OrthodonticDZD1Repackager 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
March 12, 2021K201410VENUS Bracket, ROSE BracketNJMSubstantially EquivalentGni Co., Ltd.accessdata.fda.gov
August 28, 2020K191041Orthodontic Fixation Screw [Smart Anchor Miniscrew]OATSubstantially EquivalentGni Co., Ltd.accessdata.fda.gov
February 13, 2020K192233LED Curing LightEBZSubstantially EquivalentFoshan Cicada Dental Instrument Co, Ltd.accessdata.fda.gov
November 15, 2019K182672ROSA BracketNJMSubstantially EquivalentGni Co., Ltd.accessdata.fda.gov
June 9, 2011K103019KJ MASKDZBSubstantially EquivalentKj Meditech Co., Ltd.accessdata.fda.gov
January 14, 1992K913854ORTHO LIGHT CUREDYHSubstantially EquivalentOrtho Sourceaccessdata.fda.gov
April 17, 1986K861258PERMABAND (ORTHODONTIC ADHESIVE)DYHSubstantially EquivalentOrtho Sourceaccessdata.fda.gov
March 25, 1986K860959DEPENDABONDDYHSubstantially EquivalentOrtho Sourceaccessdata.fda.gov

Compare with other makers

Updated March 12, 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.