Facility

ASI MEDICAL, INC.

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	1000160293
Establishment type	Manufacture Medical Device
Location	8811 AMERICAN WAY STE 130 ENGLEWOOD, CO, US 80112
Registration status	Active · expires 2026
Parent company	ASI MEDICAL, INC. (owner-operator 9008677)
Brand names	Triton Dental System; Advanced Dental System; Advanced Endodontic System

Activity by year

Recalls (1)

Devices registered here (8)

Activator, Ultraviolet, For Polymerization
Product code EBZ (opens in a new tab) · Class II · Dental · 21 CFR 872.6070
Plugger, Root Canal, Endodontic
Product code EKR (opens in a new tab) · Class I · Dental · 21 CFR 872.4565
Unit, Operative Dental
Product code EIA (opens in a new tab) · Class I · Dental · 21 CFR 872.6640
Locator, Root Apex
Product code LQY (opens in a new tab) · Unclassified · Unknown
Scaler, Ultrasonic
Product code ELC (opens in a new tab) · Class II · Dental · 21 CFR 872.4850
Handpiece, Belt And/Or Gear Driven, Dental
Product code EFA (opens in a new tab) · Class I · Dental · 21 CFR 872.4200
Handpiece, Direct Drive, Ac-Powered
Product code EKX (opens in a new tab) · Class I · Dental · 21 CFR 872.4200
Drill, Bone, Powered
Product code DZI (opens in a new tab) · Class II · Dental · 21 CFR 872.4120

Recalls & enforcement

Class IITerminated2013-11-05
ASI Medical is initiating a field correction for the SEAC Advanced Dental System because the miniature plastic air tank can potentially rupture.

All facilities operated by ASI MEDICAL, INC.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “ASI MEDICAL, INC. (FEI 1000160293) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000160293-asi-medical-inc/

Not open yet

Alerts for ASI MEDICAL, INC.

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.