Data / Medical devices / United States / Asi Medical, Inc.

Asi Medical, Inc.: FDA-registered device maker in Englewood, CO, United States, 2 510(k) clearances

Name: Asi Medical, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Asi Medical, Inc. is registered with the FDA (registration 1722638) in Englewood, CO, United States. It lists 8 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 28, 2013. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 1722638
FEI number: 1000160293
Address: 8811 American Way Ste 130, Englewood, CO, United States, 80112
Owner or operator: ASI MEDICAL, INC. (9008677)
Roles: Manufacturer
First device listed: October 9, 2012
Registered through: 2027
Brand names listed: Advanced Dental System, Advanced Endodontic System, Triton Dental System, Triton Self Contained Dental System

Devices it lists

Device	Product code	Class	Role	Source
Activator, Ultraviolet, For Polymerization	EBZ	2	Manufacturer	accessdata.fda.gov
Drill, Bone, Powered	DZI	2	Manufacturer	accessdata.fda.gov
Handpiece, Belt And/Or Gear Driven, Dental	EFA	1	Manufacturer	accessdata.fda.gov
Handpiece, Direct Drive, Ac-Powered	EKX	1	Manufacturer	accessdata.fda.gov
Locator, Root Apex	LQY	U	Manufacturer	accessdata.fda.gov
Plugger, Root Canal, Endodontic	EKR	1	Manufacturer	accessdata.fda.gov
Scaler, Ultrasonic	ELC	2	Manufacturer	accessdata.fda.gov
Unit, Operative Dental	EIA	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
March 28, 2013	K123139	ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES	ELC	Substantially Equivalent	Asi Medical, Inc.	accessdata.fda.gov
April 5, 2012	K110481	TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASE	EIA	Substantially Equivalent	Asi Medical, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
November 5, 2013	66983	Class II	Terminated	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	ASI Medical is initiating a field correction for the SEAC Advanced Dental System because the miniature plastic air tank can potentially rupture.	accessdata.fda.gov

Compare with other makers

Updated December 19, 2013. 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.