AMERICAN EAGLE INSTRUMENTS
Registration 3027615FEI 1000127001Missoula, MT
Owner/operator: Young Innovations Inc
- Manufacture Medical Device
- Manufacture Medical Device for Another Party (Contract Manufacturer)
- 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.
90days left in the window
The 2026 window
- Oct 1Window opens91 days left
- Nov 3Where you stand58 days left
- Dec 1Our pay-by date30 days left
- Dec 15Two weeks left16 days left
- Dec 23Holiday week8 days left
- Dec 29Two days left2 days left
- Dec 31Window closes0 days left
- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 31
- Added, last 12 months
- 7
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 |
|---|---|---|---|---|
| ELC | Kerr Ultrasonic Diamond TIpsScaler, Ultrasonic | Class 2 | 21 CFR 872.4850 | — |
| ELC | Diamond Coated TipScaler, Ultrasonic | Class 2 | 21 CFR 872.4850 | — |
| ELC | DEL ULTRASONIC TIPSScaler, Ultrasonic | Class 2 | 21 CFR 872.4850 | — |
| ELC | Kerr Ultrasonic TIpsScaler, Ultrasonic | Class 2 | 21 CFR 872.4850 | — |
| EJL | Dental Cadre Bur 5Bur, Dental | Class 1 | 21 CFR 872.3240 | — |
| EKJ | AEI BurnishersBurnisher, Operative | Class 1 | 21 CFR 872.4565 | — |
| EKH | AEI CarversCarver, Dental Amalgam, Operative | Class 1 | 21 CFR 872.4565 | — |
| EMM | Surgical Instruments - ChiselChisel, Osteotome, SurgicalAdded Dec 18, 2025 | Class 1 | 21 CFR 872.4565 | — |
| HXD | Surgical Instruments - ClampClampAdded Dec 18, 2025 | Class 1 | 21 CFR 878.4800 | — |
| EMS | AEI Double GraceysCurette, Periodontic | Class 1 | 21 CFR 872.4565 | — |
| FZS | Surgical Instruments - CuretteCurette, Surgical, General UseAdded Dec 18, 2025 | Class 1 | 21 CFR 878.4800 | — |
| EMJ | Surgical Instruments - Hand InstrumentElevator, Surgical, Dental | Class 1 | 21 CFR 872.4565 | — |
and 19 more on your full dossier
What changed
- Dec 18, 2025Listing added: EMM — Surgical Instruments - Chisel
- Dec 18, 2025Listing added: HXD — Surgical Instruments - Clamp
- Dec 18, 2025Listing added: FZS — Surgical Instruments - Curette
- Dec 18, 2025Listing added: EFL — Surgical Instruments - Forceps
- Jun 1, 2026Listing added: EMH — AEI Surgical Instruments Dental Rongeurs
- Dec 18, 2025Listing added: GDZ — Surgical Instruments - Scalpel
- Dec 18, 2025Listing added: GAD — Surgical Instruments - Retractor