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Advanced Endodontic System 90-2125E

by Asi Medical, Inc.

Advanced Endodontic System 90-2125E is a device classified as Unclassified made by Asi Medical, Inc., cleared under FDA 510(k) K123139 on 28 Mar 2013 and listed in FDA GUDID since 31 Oct 2016 (UDI-DI 00850309007183), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K123139

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850309007183 UDI-DI Date31 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK123139 Date28 Mar 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K123139 decided 28 Mar 2013 Active
  • FDA GUDID UDI-DI 00850309007183 listed 31 Oct 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K123139
  2. Listed FDA GUDID 00850309007183

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Advanced Endodontic System
Generic name
Laparoscopic wound closure thread
Model / Ref / Catalog
90-2125E
Primary DI / UDI-DI
00850309007183
510(k) Number
FDA product code
LQY, EKX, EKR, EFA, EBZ, DZI, EIA, ELC
GMDN term
Laparoscopic wound closure thread
Device class
U
Regulation number
872.4200, 872.4565, 872.6070, 872.4120, 872.6640, 872.4850
GUDID distribution status
In Commercial Distribution

Related devices

Category: Laparoscopic wound closure thread

Cleared under the same submission (K123139)

and 8 more cleared under K123139

Similar devices

Other devices filed under FDA product code LQY (Locator, Root Apex).

Other devices from Asi Medical, Inc.

See all devices from Asi Medical, Inc. →

Properties

  • Implantable
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)