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Promark Aeu-27T

by Aseptico, Inc.

Promark Aeu-27T is a Class I device made by Aseptico, Inc., listed in FDA GUDID since 15 Jun 2018 (UDI-DI 10817417020074), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10817417020074 UDI-DI Date15 Jun 2018ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Promark
Generic name
Dental surgical power tool motor, electric
Model / reference
AEU-27T
Description
HANDPIECE, DIRECT DRIVE, AC-POWERED Endodontic motor with rotary and reciprocation drive, featuring a high torque brushless motor.
Primary DI / UDI-DI
10817417020074
FDA product code
EKX
GMDN term
Dental surgical power tool motor, electric
Device class
Class I
Regulation number
872.4200
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Dental surgical power tool motor, electric

Similar devices

Other devices filed under FDA product code EKX (Handpiece, Direct Drive, Ac-Powered).

Other devices from Aseptico, Inc.

See all devices from Aseptico, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Serial number
Other properties (12, all answered No)