Manufacturer registered with FDA
Asi Medical, Inc.
Englewood, CO, United States. Lists 7 dental device types with FDA across 1 registered establishment, and holds 5 510(k) clearances as applicant.
- Device types listed
- 7
- Brands and models
- 22
- 510(k) clearances
- 51994–2013
- Markets registered in
- 44 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 1990–2026
Registered in 4 markets
Where regulators' registries name Asi Medical, Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Asi Medical, Inc. | 5 clearances | 1994–2013 | Below |
| Canada | Health Canada | Registration holder | ASI MEDICAL, INC. | 2 | 2013–2013 | Pure Global AI |
| Australia | TGA | Manufacturer | ASI Medical Inc | 1 | 2025–2025 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | ASI MEDICAL, INC. | 1 | 2011–2011 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Asi Medical, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Operative Dental UnitEIA · Class 1 | Dental chairs & operative units | Maker | Advanced Dental SystemAdvanced Endodontic SystemTriton Dental SystemTriton Self Contained Dental System | 2012 |
| Powered Bone DrillDZI · Class 2 | Surgical drills & motors | Maker | Advanced Dental SystemAdvanced Endodontic SystemTriton Dental System | 2013 |
| Ultraviolet Activator for PolymerizationEBZ · Class 2 | Curing lights | Maker | Advanced Dental SystemAdvanced Endodontic SystemTriton Dental System | 2013 |
| Dental Belt and/or Gear Driven HandpieceEFA · Class 1 | Dental handpieces | Maker | Advanced Dental SystemAdvanced Endodontic SystemTriton Dental System | 2013 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Maker | Advanced Dental SystemAdvanced Endodontic SystemTriton Dental System | 2013 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Maker | Advanced Dental SystemAdvanced Endodontic SystemTriton Dental System | 2013 |
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Maker | Advanced Dental SystemAdvanced Endodontic SystemTriton Dental System | 2013 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Asi Medical, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 28 Mar 2013 | K123139 | ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES | ELC Ultrasonic Scaler |
| 5 Apr 2012 | K110481 | TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASE | EIA Operative Dental Unit |
| 26 May 1998 | K974488 | AIRPREP SYSTEM - MODEL 9001 | KOJ Airbrush |
| 18 Feb 1998 | K974487 | SEAC ADVANCED DENTAL SYSTEM - MODEL 2001,2010 OR MODEL 2020 | EIA Operative Dental Unit |
| 7 Mar 1994 | K932873 | SEAC MOBILE UNIT BY ASI MEDICAL | EIA Operative Dental Unit |
Some of these clearances are listed with FDA today by another company: W&H Dentalwerk Buermoos GmbH (2).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ASI MEDICAL, INC.FDA reg. 1722638 | ENGLEWOOD, CO, United States | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9008677). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.