ASI MEDICAL, INC.

FDA Device Registration & Listing · ENGLEWOOD, CO, US · Registration 1722638

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1722638
FEI Number
1000160293
Entity Name
ASI MEDICAL, INC.
City/State/Country
ENGLEWOOD, CO, US
Establishment Address
8811 AMERICAN WAY STE 130, ENGLEWOOD, CO 80112, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
ASI MEDICAL, INC. (Owner Number: 9008677)
Owner / Operator Contact Address
8811 American Way, SUITE 130, Englewood, CO 80112, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K110481
PMA Number
N/A

All Registered Proprietary Names

Advanced Dental System Advanced Endodontic System Triton Dental System Triton Self Contained Dental System Advanced Endodontic System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EBZ Activator, Ultraviolet, For Polymerization Dental Class 2 872.6070 2013-10-30
EKR Plugger, Root Canal, Endodontic Dental Class 1 872.4565 2013-10-30
EIA Unit, Operative Dental Dental Class 1 872.6640 2013-10-30
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2013-10-30
LQY Locator, Root Apex Unknown Class U N/A 2013-10-30
EFA Handpiece, Belt And/Or Gear Driven, Dental Dental Class 1 872.4200 2013-10-30
EKX Handpiece, Direct Drive, Ac-Powered Dental Class 1 872.4200 2013-10-30
DZI Drill, Bone, Powered Dental Class 2 872.4120 2013-10-30
EIA Unit, Operative Dental Dental Class 1 872.6640 2012-10-09

Official Correspondent

JOHN MCPEEK

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ASI MEDICAL, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K243921 Foshan Coxo Medical Instrument Co., Ltd. LED Curing Lights (DB686 HALO) 2025-04-11
K033201 Apoza Enterprise Co., Ltd. LA500 BLUE LIGHT 2003-12-02
K832443 California Technics, Inc. ULTRASONIC DENTAL PROPHYLAXIS UNIT 1983-09-12
K994299 Bonart Co., Ltd. ART-P3, MODEL P3-1-ART-A1 2000-03-06
K241065 Dentis Co., Ltd. ChecQ (AC100) 2025-03-21

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1722638. Last updated year: 2026. Please use registration number 1722638 when referencing this establishment in official correspondence.
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