Data / Medical devices / United States / Aseptico, Inc.
Aseptico, Inc.: FDA-registered device maker in Woodinville, WA, United States, 14 510(k) clearances
Aseptico, Inc. is registered with the FDA (registration 3017604) in Woodinville, WA, United States. It lists 20 device types. The FDA files 14 510(k) clearances under its listings, the newest dated February 11, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017604
- Address
- 8333 216th St SE, Woodinville, WA, United States, 98072
- Owner or operator
- ASEPTICO, INC. (3017604)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Specification developer
- First device listed
- October 16, 2002
- Registered through
- 2026
- Brand names listed
- A111000000000 - Calamus Heated Plugger - Small, A112000000000 - Calamus Heated Plugger - Medium, A113000000000 - Calamus Heated Plugger - Large, A113000000000 - Calamus Heated Plugger - Large, A115000000000 - Calamus thermal response, A120600000000 - Replacement Cartridge Nut, A120700000000 - Cartridge Needle Bending Tool, A120800000000 - Calamus Dual Hand Piece Cleaning Brush and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Chair, Dental, Without Operative Unit | NRU | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Clamp, Rubber Dam | EEF | 1 | Complaint file establishment | accessdata.fda.gov |
| Controller, Foot, Handpiece And Cord | EBW | 1 | Complaint file establishment | accessdata.fda.gov |
| Dam, Rubber | EIE | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Forceps, Rubber Dam Clamp | EJG | 1 | Complaint file establishment | accessdata.fda.gov |
| Frame, Rubber Dam | EJE | 1 | Complaint file establishment | accessdata.fda.gov |
| Gutta-Percha | EKM | 1 | Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Handle, Instrument, Dental | EJB | 1 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Handpiece, Air-Powered, Dental | EFB | 1 | Complaint file establishment | accessdata.fda.gov |
| Handpiece, Contra- And Right-Angle Attachment, Dental | EGS | 1 | Complaint file establishment | accessdata.fda.gov |
| Handpiece, Direct Drive, Ac-Powered | EKX | 1 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Instruments, Dental Hand | DZN | 1 | Manufacturer for export | accessdata.fda.gov |
| Light, Operating, Dental | EAZ | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Motor, Surgical Instrument, Ac-Powered | GEY | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Plugger, Root Canal, Endodontic | EKR | 1 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Scaler, Ultrasonic | ELC | 2 | Complaint file establishment, Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Syringe, Cartridge | EJI | 2 | Complaint file establishment | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Unit, Operative Dental | EIA | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Wire, Orthodontic | DZC | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 11, 2021 | K201292 | TRAUS SIP20 | EBW | Substantially Equivalent | Saeshin Precision Co., Ltd. | accessdata.fda.gov |
| May 28, 2015 | K150129 | AEU-7000L-70V IMPLANT/ENDODONTIC DENTAL SYSTEM (LIGHTED VERSION) | EKX | Substantially Equivalent | Aseptico, Inc. | accessdata.fda.gov |
| December 31, 2014 | K142124 | AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM | EKX | Substantially Equivalent | Aseptico, Inc. | accessdata.fda.gov |
| August 14, 2013 | K130693 | AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEM | ELC | Substantially Equivalent | Aseptico, Inc. | accessdata.fda.gov |
| June 14, 2011 | K111078 | AEU-26L ELCTRONIC ENDODONTIC SYSTEM | EKX | Substantially Equivalent | Aseptico, Inc. | accessdata.fda.gov |
| April 11, 2011 | K101332 | AMC-20 PORTABLE DENTAL CART MODEL AMC-20 | EIA | Substantially Equivalent | Aseptico, Inc. | accessdata.fda.gov |
| February 28, 2011 | K103399 | GENERAL DENISTRY MOTOR | EKX | Substantially Equivalent | Aseptico, Inc. | accessdata.fda.gov |
| October 3, 2005 | K051872 | MK-DENT LOW SPEED HANDPIECES AND ACCESSORIES INCLUDING SPARE PARTS, TUBINGS, AND LIGHT POWER SYSTEM, MODELS: LS2011 | EFB | Substantially Equivalent | Mk-Dent GmbH | accessdata.fda.gov |
| May 3, 2005 | K051077 | E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101 | EGS | Substantially Equivalent | Aseptico, Inc. | accessdata.fda.gov |
| March 18, 2005 | K050201 | AEU-14CF EXPENDITION | EIA | Substantially Equivalent | Aseptico, Inc. | accessdata.fda.gov |
| March 3, 2003 | K030163 | ASEPTICO VCT VERSATILE COMMAND TECHNOLOGY MODEL AEU-925 | EKX | Substantially Equivalent | Aseptico, Inc. | accessdata.fda.gov |
| March 4, 2002 | K020137 | AHP-66 4:1 REDUCTION CONTRANGLE: AHP-88 8:1 REDUCTION CONTRANGLE: AHP-88MP 8:1 REDUCTION CONTRANGLE - PUSH BUTTON | EGS | Substantially Equivalent | Aseptico, Inc. | accessdata.fda.gov |
| February 20, 1991 | K905401 | ASEPTIMINI UNIT, ADU-10 | EIA | Substantially Equivalent | Aseptico, Inc. | accessdata.fda.gov |
| February 3, 1989 | K884828 | HANDIDAM | EIE | Substantially Equivalent | Aseptico, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Handpiece, Direct Drive, Ac-Powered
- All makers of Handpiece, Air-Powered, Dental
- All makers of Wire, Orthodontic
- All makers of Unit, Operative Dental
- All makers of Plugger, Root Canal, Endodontic
- All makers of Tray, Surgical, Instrument
Updated February 11, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.