Aseptico ADU-17X2
Aseptico ADU-17X2 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 10817417021590), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10817417021590 | Date8 Dec 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK905401 | Date20 Feb 1991 | StatusActive |
Official records
- AccessGUDID record 10817417021590
- FDA 510(k) database K905401
Across registries
- FDA 510(k) K905401 decided 20 Feb 1991 Active
- FDA GUDID UDI-DI 10817417021590 listed 8 Dec 2022 Listed
Timeline
- Cleared FDA 510(k) K905401
- Listed FDA GUDID 10817417021590
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Aseptico
- Generic name
- Dental delivery system
- Model / reference
- ADU-17X2
- Primary DI / UDI-DI
- 10817417021590
- 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
Similar devices in this category
Other devices filed under Dental delivery system.
- Unit, Operative Dental Dental Units by DCI International, LLC
- CS 1500 6559801 by Carestream Dental LLC
- SiroCam AF 6309400 by SIRONA Dental Systems GmbH
- SiroCam UAF Plus 6679794 by SIRONA Dental Systems GmbH
- UM-1L 6680035 by CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD.
- Dental Electrical Motors SRCT2000 by ChangZhou BoMedent Medical Technology Co., Ltd.
- Dental controllers for contra angle handpieces - by SAEYANG CO.,LTD.
- K3 Mount by Osstem Implant Company., Ltd. Chair Business
- TY-E1 z1211 by Foshan Toye Dental Equipment Co., Ltd
- OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS K5 by OSSTEM IMPLANT Co., Ltd.