K&S INSTRUMENTS
Registration 3045811395FEI 3045811395Newcastle, WA
Owner/operator: K&S Instruments
- 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
- 15
- Added, last 12 months
- 15
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 15
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| NDP | Alden Dental Implant AccessoriesAccessories, Implant, Dental, EndosseousAdded Apr 1, 2026 | Class 1 | 21 CFR 872.3980 | — |
| EJL | Alden Surgical BurBur, DentalAdded Apr 1, 2026 | Class 1 | 21 CFR 872.3240 | — |
| EML | Alden Surgical ChiselChisel, Bone, SurgicalAdded Apr 1, 2026 | Class 1 | 21 CFR 872.4565 | — |
| EMM | Alden Surgical ChiselChisel, Osteotome, SurgicalAdded Apr 1, 2026 | Class 1 | 21 CFR 872.4565 | — |
| EMK | Alden Surgical CuretteCurette, Surgical, DentalAdded Apr 1, 2026 | Class 1 | 21 CFR 872.4565 | — |
| KBL | Alden Metal Tongue RetractorDepressor, Metal Tongue, SurgicalAdded Apr 1, 2026 | Class 1 | 21 CFR 874.4420 | — |
| EMJ | Alden Surgical ElevatorsElevator, Surgical, DentalAdded Apr 1, 2026 | Class 1 | 21 CFR 872.4565 | — |
| EMI | Alden Surgical Bone FileFile, Bone, SurgicalAdded Apr 1, 2026 | Class 1 | 21 CFR 872.4565 | — |
| EMH | Alden RongeursForceps, Rongeur, SurgicalAdded Apr 1, 2026 | Class 1 | 21 CFR 872.4565 | — |
| EMG | Alden Surgical ForcepsForceps, Tooth Extractor, SurgicalAdded Apr 1, 2026 | Class 1 | 21 CFR 872.4565 | — |
| EMD | Alden Surgical HemostatHemostat, SurgicalAdded Apr 1, 2026 | Class 1 | 21 CFR 872.4565 | — |
| DZN | Alden Dental Hand InstrumentsInstruments, Dental HandAdded Apr 1, 2026 | Class 1 | 21 CFR 872.4565 | — |
and 3 more on your full dossier
What changed
- Apr 1, 2026Listing added: NDP — Alden Dental Implant Accessories
- Apr 1, 2026Listing added: EJL — Alden Surgical Bur
- Apr 1, 2026Listing added: EML — Alden Surgical Chisel
- Apr 1, 2026Listing added: EMM — Alden Surgical Chisel
- Apr 1, 2026Listing added: EMK — Alden Surgical Curette
- Apr 1, 2026Listing added: KBL — Alden Metal Tongue Retractor
- Apr 1, 2026Listing added: EMJ — Alden Surgical Elevators
- Apr 1, 2026Listing added: EMI — Alden Surgical Bone File
- Apr 1, 2026Listing added: EMH — Alden Rongeurs
- Apr 1, 2026Listing added: EMG — Alden Surgical Forceps
- Apr 1, 2026Listing added: EMD — Alden Surgical Hemostat
- Apr 1, 2026Listing added: DZN — Alden Dental Hand Instruments
- Apr 1, 2026Listing added: EMO — Alden Periodontic Knife
- Apr 1, 2026Listing added: EIX — Alden Periodontic Probe
- Apr 1, 2026Listing added: EGN — Alden Surgical Scissors