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Data / Medical devices / United States / HSG-S Corp

HSG-S Corp: FDA-registered device maker in Savannah, GA, United States, 13 510(k) clearances

HSG-S Corp is registered with the FDA (registration 3042866301) in Savannah, GA, United States. It lists 23 device types. The FDA files 13 510(k) clearances under its listings, the newest dated August 27, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3042866301
Address
800 King George BLVD Suite 200, Savannah, GA, United States, 31419
Owner or operator
HSG-S Corp (10094908)
Roles
Manufacturer, Repackager or relabeler
First device listed
January 5, 2026
Registered through
2026
Brand names listed
Barrel, Beveled Cylinder, Bud, Diablo, Durabraze, Edge C-File, Edge Hedstroms, Edge Irrigation Probe Tips and more

Devices it lists

DeviceProduct codeClassRoleSource
Broach, EndodonticEKW1Repackager or relabeleraccessdata.fda.gov
Bur, DentalEJL1Repackager or relabeleraccessdata.fda.gov
Carrier, Amalgam, OperativeEKI1Repackager or relabeleraccessdata.fda.gov
Cleanser, Root CanalKJJURepackager or relabeleraccessdata.fda.gov
Dam, RubberEIE1Repackager or relabeleraccessdata.fda.gov
Explorer, OperativeEKB1Repackager or relabeleraccessdata.fda.gov
File, Pulp Canal, EndodonticEKS1Repackager or relabeleraccessdata.fda.gov
Gauge, Depth, Instrument, DentalEIL1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Gutta-PerchaEKM1Manufactureraccessdata.fda.gov
Handpiece, Direct Drive, Ac-PoweredEKX1Repackager or relabeleraccessdata.fda.gov
Instrument, Diamond, DentalDZP1Repackager or relabeleraccessdata.fda.gov
Instrument, Filling, Plastic, DentalEIY1Repackager or relabeleraccessdata.fda.gov
Locator, Root ApexLQYURepackager or relabeleraccessdata.fda.gov
Needle, DentalDZM1Repackager or relabeleraccessdata.fda.gov
Plugger, Root Canal, EndodonticEKR1Repackager or relabeleraccessdata.fda.gov
Point, Paper, EndodonticEKN1Repackager or relabeleraccessdata.fda.gov
Reamer, Pulp Canal, EndodonticEKP1Repackager or relabeleraccessdata.fda.gov
Resin, Root Canal FillingKIF2Repackager or relabeleraccessdata.fda.gov
Scaler, UltrasonicELC2Repackager or relabeleraccessdata.fda.gov
Strip, Polishing AgentEHM1Repackager or relabeleraccessdata.fda.gov
Syringe, Periodontic, Endodontic, IrrigatingEIC1Repackager or relabeleraccessdata.fda.gov
Syringe, Restorative And Impression MaterialEID1Repackager or relabeleraccessdata.fda.gov
Tester, PulpEAT2Repackager 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 27, 2024K241354Sealer SolventKJJSubstantially EquivalentInter-Med, Inc.accessdata.fda.gov
May 10, 2021K203320Endo MotorEKXSubstantially EquivalentGuilin Woodpecker Medical Instrument Co., Ltd.accessdata.fda.gov
September 9, 2020K193409Vista Rinse, Vista Rinse PlusKJJSubstantially EquivalentInter-Med/Vista Dental Productsaccessdata.fda.gov
December 18, 2018K181087Apex Locator, DPEX IIILQYSubstantially EquivalentGuilin Woodpecker Medical Instrument Co., Ltd.accessdata.fda.gov
August 31, 2018K180185BIO-C REPAIRKIFSubstantially EquivalentAngelus Industria DE Produtos Odontologicos S/Aaccessdata.fda.gov
January 4, 2018K172701BIO-C SEALERKIFSubstantially EquivalentAngelus Industria DE Produtos Odontologicos S/Aaccessdata.fda.gov
July 25, 2016K160577PacEndo ChlorhexidineKJJSubstantially EquivalentPac-Dent International, Inc.accessdata.fda.gov
February 1, 2016K153528PacEndo EDTAKJJSubstantially EquivalentPac-Dent International, Inc.accessdata.fda.gov
November 10, 2015K151852PacEndo Sodium HyprochloriteKJJSubstantially EquivalentPac-Dent International, Inc.accessdata.fda.gov
March 11, 2014K132322NEWTRON P5 XS B.LEDELCSubstantially EquivalentSatelec - Acteon Groupaccessdata.fda.gov
September 28, 2009K092715IROOT BP PLUSKIFSubstantially EquivalentInnovative Bioceramix, Inc.accessdata.fda.gov
April 9, 2008K080917IROOT SPKIFSubstantially EquivalentInnovative Bioceramix, Inc.accessdata.fda.gov
August 21, 2006K053555ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-LELCSubstantially EquivalentGuilin Woodpecker Medical Instrument Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated August 27, 2024. 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.