ASEPTICO, INC.
Registration 3017604FEI 3017604WOODINVILLE, WA
Owner/operator: ASEPTICO, INC.
- Complaint File Establishment per 21 CFR 820.198
- Develop Specifications But Do Not Manufacture At This Facility
- Manufacture Device in the United States for Export Only
- Manufacture Medical Device
- Manufacture Medical Device for Another Party (Contract Manufacturer)
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
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- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 34
- Added, last 12 months
- 5
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 34
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| ELC | AEU-350 - ASEPTICO GO ULTRA PORTABLE DENTAL SYSTEMScaler, Ultrasonic | Class 2 | 21 CFR 872.4850 | — |
| ELC | AEU-350 - ASEPTICO GO ULTRA PORTABLE DENTAL SYSTEMScaler, Ultrasonic | Class 2 | 21 CFR 872.4850 | K130693 |
| EJI | CAL-2118 CalajectSyringe, Cartridge | Class 2 | 21 CFR 872.6770 | — |
| NRU | ADC-01 -ASEPTICHAIR WITH CASEChair, Dental, Without Operative Unit | Class 1 | 21 CFR 872.6250 | — |
| EEF | K-0 - RUBBER DAM CLAMP BICUSPID #0Clamp, Rubber Dam | Class 1 | 21 CFR 872.6300 | — |
| EBW | AHP-85-SS Handpiece, contra-and right angle attachment, dentalController, Foot, Handpiece And CordAdded Mar 5, 2026 | Class 1 | 21 CFR 872.4200 | K201292 |
| EIE | I-70BM - HANDIDAM W/PLASTIC FRAME BLUE PKG OF 20Dam, Rubber | Class 1 | 21 CFR 872.6300 | K884828 |
| EJG | I-14 - FORCEP RUBBER DAMForceps, Rubber Dam Clamp | Class 1 | 21 CFR 872.6300 | — |
| EJE | I-16 - RUBBER DAM FRAME ADULTFrame, Rubber Dam | Class 1 | 21 CFR 872.6300 | — |
| EKM | BNSG1QA0025G Gutta-Smart GP Crtg 25G-10 PackGutta-Percha | Class 1 | 21 CFR 872.3850 | — |
| EKM | GP-018CP-DS - GUTTA PERCHA 18 PACKAGED CARTRIDGE FOR AEU-65-DSGutta-Percha | Class 1 | 21 CFR 872.3850 | — |
| EJB | AEU-45 FAMILYHandle, Instrument, Dental | Class 1 | 21 CFR 872.4565 | — |
and 22 more on your full dossier
What changed
- Mar 5, 2026Listing added: EBW — AHP-85-SS Handpiece, contra-and right angle attachment, dental (K201292)
- Mar 5, 2026Listing added: EGS — AHP-85-SS Handpiece, contra-and right angle attachment, dental (K201292)
- Dec 16, 2025Listing added: EKX — AEU-7000E-70V-W (K150129)
- Mar 24, 2026Listing added: EKY — AHP-85-SS Handpiece, contra-and right angle attachment, dental (K123695)
- Apr 8, 2026Listing added: FSM — AA-1070TRE-TRAY -- INSTRUMENT TRAY TREACE PERCUPLASTY MIS POWER SYSTEM