HSG-S CORP
Registration 3042866301FEI 3042866301Savannah, GA
Owner/operator: HSG-S Corp
- Manufacture Medical Device
- Repack or Relabel Medical Device
Renewal due by December 31, 2026
Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.
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The 2026 window
- Oct 1Window opens91 days left
- Nov 3Where you stand58 days left
- Dec 1Our pay-by date30 days left
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- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 31
- Added, last 12 months
- 31
FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page
The steps, in order
Pay FDA's annual feeYou
Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.
FDA: registration and listing payment processWait for the payment confirmation numberYou
FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.
FDA: registration and listing payment processRenew the registration in FDA's systemYou
Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.
FDA: device registration and listingReview every listingYou
In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.
FDA: device registration and listing
Every listed device 31
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| KIF | EdgeBioCeramic SealerResin, Root Canal FillingAdded Aug 28, 2026 | Class 2 | 21 CFR 872.3820 | K080917 |
| KIF | EdgeBioCeramic RetroFill and Perforation RepairResin, Root Canal FillingAdded Aug 28, 2026 | Class 2 | 21 CFR 872.3820 | K092715 |
| KIF | EdgeUtopia RRMResin, Root Canal FillingAdded Aug 28, 2026 | Class 2 | 21 CFR 872.3820 | K180185 |
| KIF | EdgeUtopia Bioceramic SealerResin, Root Canal FillingAdded Aug 28, 2026 | Class 2 | 21 CFR 872.3820 | K172701 |
| ELC | EdgeActivator E70 TipScaler, UltrasonicAdded Aug 28, 2026 | Class 2 | 21 CFR 872.4850 | K053555 |
| ELC | EdgeSurgicalTipScaler, UltrasonicAdded Aug 28, 2026 | Class 2 | 21 CFR 872.4850 | K132322 |
| EAT | EdgeIceTester, PulpAdded Aug 27, 2026 | Class 2 | 21 CFR 872.1720 | — |
| EKW | EdgeBroachesBroach, EndodonticAdded Mar 12, 2026 | Class 1 | 21 CFR 872.4565 | — |
| EJL | BarrelBur, DentalAdded Jan 5, 2026 | Class 1 | 21 CFR 872.3240 | — |
| EKI | EdgeUtopia RRM Dispensing GunCarrier, Amalgam, OperativeAdded Aug 27, 2026 | Class 1 | 21 CFR 872.4565 | — |
| EIE | EdgeDamDam, RubberAdded Aug 27, 2026 | Class 1 | 21 CFR 872.6300 | — |
| EKB | NordentExplorer, OperativeAdded Aug 27, 2026 | Class 1 | 21 CFR 872.4565 | — |
and 19 more on your full dossier
What changed
- Aug 28, 2026Listing added: KIF — EdgeBioCeramic Sealer (K080917)
- Aug 28, 2026Listing added: KIF — EdgeBioCeramic RetroFill and Perforation Repair (K092715)
- Aug 28, 2026Listing added: KIF — EdgeUtopia RRM (K180185)
- Aug 28, 2026Listing added: KIF — EdgeUtopia Bioceramic Sealer (K172701)
- Aug 28, 2026Listing added: ELC — EdgeActivator E70 Tip (K053555)
- Aug 28, 2026Listing added: ELC — EdgeSurgicalTip (K132322)
- Aug 27, 2026Listing added: EAT — EdgeIce
- Mar 12, 2026Listing added: EKW — EdgeBroaches
- Jan 5, 2026Listing added: EJL — Barrel
- Aug 27, 2026Listing added: EKI — EdgeUtopia RRM Dispensing Gun
- Aug 27, 2026Listing added: EIE — EdgeDam
- Aug 27, 2026Listing added: EKB — Nordent
- Jan 5, 2026Listing added: EKS — Edge C-File
- Jul 27, 2026Listing added: EIL — EdgeEndo®
- Jan 5, 2026Listing added: EKM — EdgeAccessory
- Aug 27, 2026Listing added: EKX — EdgeApex HP (K203320)
- Aug 27, 2026Listing added: DZP — Durabraze
- Aug 28, 2026Listing added: EIY — EdgeBioCeramic Tips
- Jan 5, 2026Listing added: DZM — Edge Irrigation Probe Tips
- Aug 27, 2026Listing added: EKR — EdgeEndo®
- Jan 5, 2026Listing added: EKN — Point, Paper, Endodontic
- Jan 5, 2026Listing added: EKP — Reamer, Pulp Canal, Endodontic
- Jan 5, 2026Listing added: EHM — Strip, Polishing Agent
- Aug 27, 2026Listing added: EIC — Edge®
- Jan 5, 2026Listing added: EID — Syringe, Restorative And Impression Material
- Aug 28, 2026Listing added: KJJ — EdgeEndo® 5% Sodium Hypochlorite (K151852)
- Mar 2, 2026Listing added: KJJ — EdgeMix (K193409)
- Mar 2, 2026Listing added: KJJ — EdgeUtopia BC Solvent (K241354)
- Aug 28, 2026Listing added: KJJ — EdgeEndo® 17% EDTA (K153528)
- Aug 28, 2026Listing added: KJJ — EdgeEndo® 2% Chlorhexidine Gluconate (K160577)
- Aug 28, 2026Listing added: LQY — EdgeApex File Clip (K181087)