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
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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 27, 2024 | K241354 | Sealer Solvent | KJJ | Substantially Equivalent | Inter-Med, Inc. | accessdata.fda.gov |
| May 10, 2021 | K203320 | Endo Motor | EKX | Substantially Equivalent | Guilin Woodpecker Medical Instrument Co., Ltd. | accessdata.fda.gov |
| September 9, 2020 | K193409 | Vista Rinse, Vista Rinse Plus | KJJ | Substantially Equivalent | Inter-Med/Vista Dental Products | accessdata.fda.gov |
| December 18, 2018 | K181087 | Apex Locator, DPEX III | LQY | Substantially Equivalent | Guilin Woodpecker Medical Instrument Co., Ltd. | accessdata.fda.gov |
| August 31, 2018 | K180185 | BIO-C REPAIR | KIF | Substantially Equivalent | Angelus Industria DE Produtos Odontologicos S/A | accessdata.fda.gov |
| January 4, 2018 | K172701 | BIO-C SEALER | KIF | Substantially Equivalent | Angelus Industria DE Produtos Odontologicos S/A | accessdata.fda.gov |
| July 25, 2016 | K160577 | PacEndo Chlorhexidine | KJJ | Substantially Equivalent | Pac-Dent International, Inc. | accessdata.fda.gov |
| February 1, 2016 | K153528 | PacEndo EDTA | KJJ | Substantially Equivalent | Pac-Dent International, Inc. | accessdata.fda.gov |
| November 10, 2015 | K151852 | PacEndo Sodium Hyprochlorite | KJJ | Substantially Equivalent | Pac-Dent International, Inc. | accessdata.fda.gov |
| March 11, 2014 | K132322 | NEWTRON P5 XS B.LED | ELC | Substantially Equivalent | Satelec - Acteon Group | accessdata.fda.gov |
| September 28, 2009 | K092715 | IROOT BP PLUS | KIF | Substantially Equivalent | Innovative Bioceramix, Inc. | accessdata.fda.gov |
| April 9, 2008 | K080917 | IROOT SP | KIF | Substantially Equivalent | Innovative Bioceramix, Inc. | accessdata.fda.gov |
| August 21, 2006 | K053555 | ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L | ELC | Substantially Equivalent | Guilin Woodpecker Medical Instrument Co., Ltd. | accessdata.fda.gov |
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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.