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Advanced Endodontic System- Designer Series

by Asi Medical, Inc.

510(k) K123139

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK123139 Date28 Mar 2013ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
ELC
Device class
Class II
Regulation
21 CFR Part 872.4850
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is an ultrasonic scaler, classified as a Class II medical device under FDA regulation number 872.4850. It is designed for dental use and has been determined to be substantially equivalent to a predicate device through a traditional 510(k) clearance process.

The device is manufactured by Asi Medical, Inc. and is authorized under FDA 510(k) clearance K123139. It is supplied as a reusable system intended for use in dental treatment rooms, with no indication of sterility, single-use status, or MRI safety provided in the data.

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