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Aseptico ADU-22

by Aseptico, Inc.

Aseptico ADU-22 is a Class I device made by Aseptico, Inc., cleared under FDA 510(k) K905401 on 20 Feb 1991 and listed in FDA GUDID since 8 Dec 2022 (UDI-DI 10817417021613), active as of 23 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 23 Oct 2026

Documents

510(k) K905401

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10817417021613 UDI-DI Date8 Dec 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK905401 Date20 Feb 1991DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K905401 decided 20 Feb 1991 Active
  • FDA GUDID UDI-DI 10817417021613 listed 8 Dec 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K905401
  2. Listed FDA GUDID 10817417021613

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Aseptico
Generic name
Dental delivery system
Model / reference
ADU-22
Primary DI / UDI-DI
10817417021613
510(k) Number
FDA product code
EIA
GMDN term
Dental delivery system
Device class
Class I
Regulation number
872.6640
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Dental delivery system

Cleared under the same submission (K905401)

and 8 more cleared under K905401

Similar devices

Also classified as Dental delivery system.

Similar devices in this category

Other devices filed under Dental delivery system.

Other devices from Aseptico, Inc.

See all devices from Aseptico, Inc. →

Properties

  • Sterilise before use
  • Serial number
Other properties (13, all answered No)