Manufacturer registered with FDA
HSG-S Corp
Savannah, GA, United States. Lists 21 dental device types with FDA across 1 registered establishment.
- Device types listed
- 21
- Brands and models
- 99
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What HSG-S Corp currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root Canal Filling ResinKIF · Class 2 | Root canal filling materials | Lister | EdgeBioCeramic RetroFill and Perforation RepairEdgeBioCeramic SealerEdgeBioCeramic ThermalFlow SealerEdgeUtopia Bioceramic SealerEdgeUtopia RRM | 2026 |
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Lister | EdgeActivator E70 TipEdgePiezo ED3D Endodontic TipEdgePiezo HandpieceEdgePiezo PD3D Subgingival TipEdgeSurgicalTipEdgeTip | 2026 |
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Lister | Edge Irrigation Probe TipsEdge Irritation Needle TipsEdgeEndo | 2026 |
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Maker | Durabraze | 2026 |
| Pulp TesterEAT · Class 2 | — | Lister | EdgeIce | 2026 |
| Polishing Agent StripEHM · Class 1 | Polishing & prophylaxis | Lister | — | 2026 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Lister | Edge® | 2026 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Lister | — | 2026 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Lister | EdgeDam | 2026 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Maker | EdgeEndo®EdgeVerifyEndoRing® | 2026 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Lister | EdgeBioCeramic Tips | 2026 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Lister | BarrelBeveled CylinderBudDiabloEggEnd Cutting Cylinder ShortFinishing Carbide BurFlameFlat End CylinderFlat End Taper 33 moreGingival CurettageGross Reduction Cylinder ShortGross Reduction Taper ShortInterdentalInverted ConeKS Cylinder ShortLong Round End TaperLong Taper Cone with Uncoated TipOperative Carbide BurOrca Metal Cutting BurPearPointed ConePolishers RevealPolishers ShineRoundRound Edge TaperRound End CylinderRound End TaperSpecialty BurTaper Cone with Rounded TipTorpedoWheelWheel ShortZirconia Cup PolishZirconia Cup ShineZirconia Knife Edge PolishZirconia Knife Edge ShineZirconia Large Point PolishZirconia Large Point ShineZirconia Small Point PolishZirconia Small Point ShineZirconia Wheel PolishZirconia Wheel Shine | 2026 |
| Operative ExplorerEKB · Class 1 | Dental hand instruments | Lister | Nordent | 2026 |
| Operative Amalgam CarrierEKI · Class 1 | Dental hand instruments | Lister | EdgeUtopia RRM Dispensing Gun | 2026 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Maker | EdgeAccessoryEdgeCore for EdgeEndo®EdgeCore for EdgeOneEdgeCore for EdgeTaperEdgeEndo®EdgeFill for EdgeEndo®EdgeFill for EdgeOneEdgeFill for EdgeTaperEdgePellets | 2026 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Lister | — | 2026 |
| Endodontic Pulp Canal ReamerEKP · Class 1 | Endodontic files | Lister | — | 2026 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Lister | EdgeEndo®EdgeFlowEdgePack | 2026 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Lister | Edge C-FileEdge HedstromsEdge K-FileEdge K-File NiTiEdgeEndoEdgeFindEdgeGatesEdgeOne Blaze UtopiaEdgeOnyxEdgeTaper 4 moreEdgeTaper Blaze UtopiaEdgeTaper RetreatEdgeUtopia C-FileEdgeUtopia K-File | 2026 |
| Endodontic BroachEKW · Class 1 | Endodontic files | Lister | EdgeBroachesEdgeEndo | 2026 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Lister | EdgeApexEdgeApex HPEdgeEndo®EdgeFlow | 2026 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
HSG-S Corp lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Guilin Woodpecker Medical Instrument Co., Ltd. (2), Angelus Industria DE Produtos Odontologicos S/A (2), Innovative Bioceramix, Inc. (2), Satelec - Acteon Group (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 10 May 2021 | K203320 | Endo Motor | Guilin Woodpecker Medical Instrument Co., Ltd. | EKX Ac-Powered Direct Drive Handpiece |
| 31 Aug 2018 | K180185 | BIO-C REPAIR | Angelus Industria DE Produtos Odontologicos S/A | KIF Root Canal Filling Resin |
| 4 Jan 2018 | K172701 | BIO-C SEALER | Angelus Industria DE Produtos Odontologicos S/A | KIF Root Canal Filling Resin |
| 11 Mar 2014 | K132322 | NEWTRON P5 XS B.LED | Satelec - Acteon Group | ELC Ultrasonic Scaler |
| 28 Sep 2009 | K092715 | IROOT BP PLUS | Innovative Bioceramix, Inc. | KIF Root Canal Filling Resin |
| 9 Apr 2008 | K080917 | IROOT SP | Innovative Bioceramix, Inc. | KIF Root Canal Filling Resin |
| 21 Aug 2006 | K053555 | ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L | Guilin Woodpecker Medical Instrument Co., Ltd. | ELC Ultrasonic Scaler |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| HSG-S CORPFDA reg. 3042866301 | Savannah, GA, United States | Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10094908). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.