ASI Medical, Inc.
Englewood, CO, US
ASI MEDICAL, INC. appears in FDA device records in Englewood, CO. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for ASI Medical, Inc. between 1994 and 2013. The busiest year on record is 1998, with 2. The most recent is 2013, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 1 |
| 1998 | 2 |
| 2012 | 1 |
| 2013 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K123139 | ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES | ELC | Substantially Equivalent | |
| K110481 | TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASE | EIA | Substantially Equivalent | |
| K974488 | AIRPREP SYSTEM - MODEL 9001 | KOJ | Substantially Equivalent | |
| K974487 | SEAC ADVANCED DENTAL SYSTEM - MODEL 2001,2010 OR MODEL 2020 | EIA | Substantially Equivalent | |
| K932873 | SEAC MOBILE UNIT BY ASI MEDICAL | EIA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1722638 | 1000160293 | ASI MEDICAL, INC. | 8811 AMERICAN WAY STE 130, ENGLEWOOD, CO 80112 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0545-2014 | SEAC Advanced Dental System, Model A591561 The SEAC Advanced Dental System is a self-contained dental delivery system with a built-in air compressor,vacuum system and water supply. It is designed operate dental handpiece attachments and suction instruments. The SEAC Advanced Dental System can also be upgraded to include a Micadent air abrasion system mounted inside the unit with the handpiece mounted in a holder along side the other handpiece connections. The Micadent is used to perform intra oral air abrasion procedures including etching and preparing surfaces for composite restoration. The SEAC Advanced Dental System is substantially similar in design and functions as the SEAC Mobile Dental System manufactured by ASI Medical, Inc. The Micadent is manufactured by Medidents and will be supplied to ASIas a completed product. The Micadent is substantially the same as it is provided and is attached to an accessory air line inside the SEAC unit for operation. It is intended for use to provide general dental restorative care and hygiene procedures in both traditional dental office settings and/or mobile applications by or under the supervision of a licensed dentist or a hygienist if permitted by applicable law. | ASI Medical is initiating a field correction for the SEAC Advanced Dental System because the miniature plastic air tank can potentially rupture. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain